36C79124Q0005 Hearing Aids-Wireless Systems PWS 04-08-2024.pdf

DRAFT

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

(1) Contractor. Contractor must maintain a letter designating primary or primary/alternate points of contact(s) with contractual authority to be contacted for prompt contract administration. Designation should be on company letterhead with the following information:

(i) Date

(ii) Contract number

(iii) Name and title of designee(s)

(iv) Address

(v) Phone and fax number

(vi) Email address

Any changes to the designated individual(s) must be provided to the Contracting Officer, in writing, with the proposed effective date of the change.

(a) The contractor shall contact the Contract Specialist or Contracting Officer on all matters pertaining to administration. Only the contracting officer is authorized to make commitments or issue changes that will affect the price, quantity, delivery or terms of the contract.

(b) The contractor shall designate a primary or primary/alternate person to serve as the contract administrator for the contract. The contract administrator is responsible for overall compliance with contract terms and conditions. The contract administrator is also the responsible official for issues concerning the Contractor’s Report of Sales and Customer User Fee (CUF). The contractor’s designation of representatives to handle certain functions under this contract does not relieve the contract administrator of responsibility for contract compliance.

b. GOVERNMENT:

Connie J. Gordon, Contracting Officer 36C791 Department of Veterans Affairs Commodities & Services Acquisition Svc (003B6E) 555 Corporate Circle Golden CO 80401-5621 Phone: 303-273-6272 Fax: 303-215-9074 Email: Connie.Gordon1@va.gov Alternate: Caroline West, Contract Specialist Phone: 303-273-6226 Fax: 303-215-9074 Email: caroline.west@va.gov

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Upon completion of delivery order

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. As shown on individual delivery orders.

B.2 IT CONTRACT SECURITY (TO BE ADDED BY CONTRACTING)

B.3. INSTRUCTIONS FOR PRICING SCHEDULE

In order to be considered for award, offerors must propose on all required Contract Line items (CLINs) for the base period (one year) and all four optional periods. Please utilize Attachment U to provide the necessary details for each CLIN for base year. The below pricing schedule should reflect the unit price and total price based on the estimated quantities and should match Attachment U.

The total estimated quantities listed in this schedule are the estimated quantities for all contract award divided by 5, as the Government anticipates awarding up to 5 contracts for this IDIQ.

Offerors are instructed to provide model name, HCPCS code, and Manufacturer’s Suggested Retail Price (MSRP) for each item the offeror is proposing. If no MSRP is available, please indicate by marking N/A in the schedule below. Chargers are to be shown priced separately from hearing aid devices. When orders are placed for a hearing aid device, a charger will be selected if needed from a drop down in ROES.

Optional CLINs will only be award if the Contracting Officer determines that such an award is in VA’s best interest and that the pricing is fair and reasonable. Failure to price all required CLINs may result in a determination of noncompliance, rejection of the proposal and exclusion from consideration for award.

Pricing is to include a Three-Year Warranty for each option year. Repairs outside of the three-year warranty should be reflected under the appropriate category.

Base Year – Pricing Schedule

A Schedule with Required (R) and Optional (O) line items as follows:

Kruger, Kelli Add in line regarding pricing for chargers.

CLIN Req or Opt

Description Ref.

Sec.

Estimated Quantity

Unit Price (per item)

Estimated Total Price

Group 1 – REQUIRED - Must propose a minimum of 1 category

1001 Category 1 B.9.2 136,250 $ $

1002 Category 2 B.9.2 734,047 $ $

1003 Category 3 B.9.2 19,658 $ $

1004 Category 4 B.9.2 870 $ $

Group 2 – REQUIRED - Must propose a minimum of 1 category

1005 Category 1 B.9.2.2 21,250 $ $

1006 Category 2 B.9.2.2 102,497 $ $

1007 Category 3 B.9.2.2 2,548 $ $

1008 Category 4 B.9.2.2 124 $ $

Group 3 – REQUIRED - Must propose a minimum of 1 category

1009 Group 3 Category 1 B.9.2.3 175,000 $ $

1010 Group 3 Category 2 B.9.2.3 4,831,692 $ $

1011 Group 3 Category 3 B.9.2.3 198,853 $ $

1012 Group 3 Category 4 B.9.2.3 200 $ $

1013 Group 3 Category 5 B.9.2.3 52,106 $ $

1014 R Group 4 Category 1 B.9.2.4 720,984 $ $

1015 O Group 4 Category 2 B.9.2.4 124,016 $ $

1016 R Group 5 B.9.2.5 1,067,394 $ $

1017 O Group 6 B.9.2.6 322,650 $ $

1018 O Group 7 Category 1 B.9.2.7 7,500 $ $

1019 O Group 7 Category 2 B.9.2.7 59,692 $ $

1020 O Group 8 Category 1 B.9.2.8 5,000 $ $

1021 O Group 8 Category 2 B.9.2.8 5,000 $ $

1022 R Group 9 B.9.2.9 2,834,118 $ $

1023 R Group 10 – Repairs – Flat Fee Wireless FM Systems

B.14.2.c 18,190 $ $

1024 R Group 10 – Repairs – Flat Fee ITE Type

B.14.2.c 175,472 $ $

1025 R Group 10 – Repairs – OE Type

B.14.2.c 179,236 $ $

1026 R Group 10 – Repairs – RIC Type

B.14.2.c 558,749 $ $

1027 R Group 10 – Repairs – RM Type

B.14.2.c 60,259 $ $

1028 R Group 10 – Repairs – WA/WS Adapter

B.14.2.c 51,341 $ $

1029 R Group 10 – Repairs – WR/WS Receiver

B.14.2.c 195 $ $

1030 R Group 10 – Repairs -

WS

B.14.2.c 118,902 $ $

CLIN Req or Opt

Description Ref.

Sec.

Estimated Quantity

Unit Price (per item)

Estimated Total Price

Group 1 – REQUIRED - Must propose a minimum of 1 category

2001 Category 1 B.9.2 136,250 $ $

2002 Category 2 B.9.2 734,047 $ $

2003 Category 3 B.9.2 19,658 $ $

2004 Category 4 B.9.2 870 $ $

Group 2 – REQUIRED - Must propose a minimum of 1 category

2005 Category 1 B.9.2.2 21,250 $ $

2006 Category 2 B.9.2.2 102,497 $ $

2007 Category 3 B.9.2.2 2,548 $ $

2008 Category 4 B.9.2.2 124 $ $

Group 3 – REQUIRED - Must propose a minimum of 1 category

2009 Category 1 B.9.2.3 175,000 $ $

2010 Category 2 B.9.2.3 4,831,692 $ $

2011 Category 3 B.9.2.3 198,853 $ $

2012 Category 4 B.9.2.3 206 $ $

2013 Category 5 B.9.2.3 52,106 $ $

2014 R Group 4 Category 1 B.9.2.4 720,984 $ $

2015 O Group 4 Category 2 B.9.2.4 124,016 $ $

2016 R Group 5 B.9.2.5 1,067,394 $ $

2017 O Group 6 B.9.2.6 322,650 $ $

2018 O Group 7 Category 1 B.9.2.7 7,500 $ $

2019 O Group 7 Category 2 B.9.2.7 59,692 $ $

2020 O Group 8 Category 1 B.9.2.8 5,000 $ $

2021 O Group 8 Category 2 B.9.2.8 5,000 $ $

2022 R Group 9 B.9.2.9 2,834,118 $ $

2023 R Group 10 – Repairs – Flat Fee Wireless FM Systems

B.14.2.c 18,736 $ $

2024 R Group 10 – Repairs – Flat Fee ITE Type

B.14.2.c 180,737 $ $

2025 R Group 10 – Repairs – OE Type

B.14.2.c 184,613 $ $

2026 R Group 10 – Repairs – RIC Type

B.14.2.c 575,512 $ $

2027 R Group 10 – Repairs – RM Type

B.14.2.c 62,067 $ $

2028 R Group 10 – Repairs – WA/WS Adapter

B.14.2.c 52,881 $ $

2029 R Group 10 – Repairs – WR/WS Receiver

B.14.2.c 201 $ $

2030 R Group 10 -Repairs

WS

B.14.2.c 122,469 $ $

CLIN Req or Opt

Description Ref.

Sec.

Estimated Quantity

Unit Price (per item)

Estimated Total Price

Group 1 – REQUIRED - Must propose a minimum of 1 category

3001 Category 1 B.9.2 136,250 $ $

3002 Category 2 B.9.2 734,047 $ $

3003 Category 3 B.9.2 19,658 $ $

3004 Category 4 B.9.2 870 $ $

Group 2 – REQUIRED - Must propose a minimum of 1 category

3005 Category 1 B.9.2.2 21,250 $ $

3006 Category 2 B.9.2.2 102,497 $ $

3007 Category 3 B.9.2.2 2,548 $ $

3008 Category 4 B.9.2.2 124 $ $

Group 3 – REQUIRED - Must propose a minimum of 1 category

3009 Category 1 B.9.2.3 175,000 $ $

3010 Category 2 B.9.2.3 4,831,692 $ $

3011 Category 3 B.9.2.3 198,853 $ $

3012 Category 4 B.9.2.3 212 $ $

3013 Category 5 B.9.2.3 52,106 $ $

3014 R Group 4 Category 1 B.9.2.4 720,984 $ $

3015 O Group 4 Category 2 B.9.2.4 124,016 $ $

3016 R Group 5 B.9.2.5 1,067,394 $ $

3017 O Group 6 B.9.2.6 322,650 $ $

3018 O Group 7 Category 1 B.9.2.7 7,500 $ $

3019 O Group 7 Category 2 B.9.2.7 59,692 $ $

3020 O Group 8 Category 1 B.9.2.8 5,000 $ $

3021 O Group 8 Category 2 B.9.2.8 5,000 $ $

3022 R Group 9 B.9.2.9 2,834,118 $ $

3023 R Group 10 – Repairs – Flat Fee Wireless FM Systems

B.14.2.c 192,298 $ $

3024 R Group 10 – Repairs – Flat Fee ITE Type

B.14.2.c 186,158 $ $

3025 R Group 10 – Repairs – OE Type

B.14.2.c 190,152 $ $

3026 R Group 10 – Repairs – RIC Type

B.14.2.c 592,777 $ $

3027 R Group 10 – Repairs – RM Type

B.14.2.c 63,929 $ $

3028 R Group 10 – Repairs – WA/WS Adapter

B.14.2.c 54,468 $ $

3029 R Group 10 – Repairs – WR/WS Receiver

B.14.2.c 207 $ $

3030 R Group 10 – Repairs -

WS

B.14.2.c 126,143 $ $

CLIN Req or Opt

Description Ref.

Sec.

Estimated Quantity

Unit Price (per item)

Estimated Total Price

Group 1 – REQUIRED - Must propose a minimum of 1 category

4001 Category 1 B.9.2 136,250 $ $

4002 Category 2 B.9.2 734,047 $ $

4003 Category 3 B.9.2 19,658 $ $

4004 Category 4 B.9.2 870 $ $

Group 2 – REQUIRED - Must propose a minimum of 1 category

4005 Category 1 B.9.2.2 21,250 $ $

4006 Category 2 B.9.2.2 102,497 $ $

4007 Category 3 B.9.2.2 2,548 $ $

4008 Category 4 B.9.2.2 124 $ $

Group 3 – REQUIRED - Must propose a minimum of 1 category

4009 Category 1 B.9.2.3 175,000 $ $

4010 Category 2 B.9.2.3 4,831,692 $ $

4011 Category 3 B.9.2.3 198,853 $ $

4012 Category 4 B.9.2.3 218 $ $

4013 Category 5 B.9.2.3 52,106 $ $

4014 R Group 4 Category 1 B.9.2.4 720,984 $ $

4015 O Group 4 Category 2 B.9.2.4 124,016 $ $

4016 R Group 5 B.9.2.5 1,067,394 $ $

4017 O Group 6 B.9.2.6 322,650 $ $

4018 O Group 7 Category 1 B.9.2.7 7,500 $ $

4019 O Group 7 Category 2 B.9.2.7 59,692 $ $

4020 O Group 8 Category 1 B.9.2.8 5,000 $ $

4021 O Group 8 Category 2 B.9.2.8 5,000 $ $

4022 R Group 9 B.9.2.9 2,834,118 $ $

4023 R Group 10 – Repairs – Flat Fee Wireless FM Systems

B.14.2.c 19,877 $ $

4024 R Group 10 – Repairs – Flat Fee ITE Type

B.14.2.c 191,743 $ $

4025 R Group 10 – Repairs – OE Type

B.14.2.c 195,856 $ $

4026 R Group 10 – Repairs – RIC Type

B.14.2.c 610,560 $ $

4027 R Group 10 – Repairs – RM Type

B.14.2.c 65,847 $ $

4028 R Group 10 – Repairs – WA/WS Adapter

B.14.2.c 56,102 $ $

4029 R Group 10 – Repairs – WR/WS Receiver

B.14.2.c 213 $ $

4030 R Group 10 – Repairs -

WS

B.14.2.c 129,927 $ $

CLIN Req or Opt

Description Ref.

Sec.

Estimated Quantity

Unit Price (per item)

Estimated Total Price

Group 1 – REQUIRED - Must propose a minimum of 1 category

5001 Category 1 B.9.2 136,250 $ $

5002 Category 2 B.9.2 734,047 $ $

5003 Category 3 B.9.2 19,658 $ $

5004 Category 4 B.9.2 870 $ $

Group 2 – REQUIRED - Must propose a minimum of 1 category

5005 Category 1 B.9.2.2 21,250 $ $

5006 Category 2 B.9.2.2 102,497 $ $

5007 Category 3 B.9.2.2 2,548 $ $

5008 Category 4 B.9.2.2 124 $ $

Group 3 – REQUIRED - Must propose a minimum of 1 category

5009 Category 1 B.9.2.3 175,000 $ $

5010 Category 2 B.9.2.3 4,831,692 $ $

5011 Category 3 B.9.2.3 198,853 $ $

5012 Category 4 B.9.2.3 225 $ $

5013 Category 5 B.9.2.3 52,106 $ $

5014 R Group 4 Category 1 B.9.2.4 720,984 $ $

5015 O Group 4 Category 2 B.9.2.4 124,016 $ $

5016 R Group 5 B.9.2.5 1,067,394 $ $

5017 O Group 6 B.9.2.6 322,650 $ $

5018 O Group 7 Category 1 B.9.2.7 7,500 $ $

5019 O Group 7 Category 2 B.9.2.7 59,692 $ $

5020 O Group 8 Category 1 B.9.2.8 5,000 $ $

5021 O Group 8 Category 2 B.9.2.8 5,000 $ $

5022 R Group 9 B.9.2.9 2,834,118 $ $

5023 R Group 10 – Repairs – Flat Fee Wireless FM Systems

B.14.2.c 20,473 $ $

5024 R Group 10 – Repairs – Flat Fee ITE Type

B.14.2.c 197,495 $ $

5025 R Group 10 – Repairs – OE Type

B.14.2.c 201,732 $ $

5026 R Group 10 – Repairs – RIC Type

B.14.2.c 628,877 $ $

5027 R Group 10 – Repairs – RM Type

B.14.2.c 67,822 $ $

5028 R Group 10 – Repairs – WA/WS Adapter

B.14.2.c 57,785 $ $

5029 R Group 10 – Repairs – WR/WS Receiver

B.14.2.c 220 $ $

5030 R Group 10 – Repairs -

WS

B.14.2.c 133,825 $ $

B.4. BACKGROUND

The Department of Veterans Affairs (VA) Commodities and Services Acquisition Service (CSAS) has identified the need for Digital Hearing Aids, Simple Wireless Remotes, Wireless Systems, Hearing Aid Earmolds, and Hearing Aid Repairs to meet the needs of U.S. military Veterans by contracting through the VA National Hearing Aid Program. The resulting contract(s) is to ensure veterans have access to integrated, specialized, evidence-based audiology and speech pathology services.

This is not a personal services contract (as described in FAR 37.104(a) and defined in FAR 2.101), Performance Based Contract and the success of this contract depends on not only the performance satisfaction of the requirement but on the satisfaction of the veteran beneficiary and VHA Clinical Staff on services received. Rather than a list of tasks of activities, this Performance Based Work Statement is an expression of VA’s requirements of the service to be performed by the Contractor(s). Effective communication between the Government and Contractor(s) is essential for partnering for this performance-based service contract to succeed.

The Government will neither supervise the Contractor’s employees nor control the method by which the Contractor(s) performs the required tasks. Under no circumstances will the Government assign tasks to, or prepare work schedules for, individual Contractor’s employees. It shall be the responsibility of the Contractor(s) to manage its employees and to guard against any actions that are of the nature of personal services or give the perception of personal services. If the Contractor(s) believes that any actions constitute personal services, it shall be the Contractor’s responsibility to notify the Contracting Officer immediately.

B.5 PURPOSE AND OBJECTIVE

The objectives of this contract are to:

(a) The purpose of this schedule is to define the requirements for the VA National Hearing Aid Program managed by the VA DLS to provide a complete wireless communication system for Veterans with hearing loss along with the repair of the devices. The system includes various types of prescription digital hearing aids, rechargeable and non-rechargeable, wireless systems and types/styles of earmolds. Optional items are digital wireless CROS transmitters, simple wireless remotes and CI compatible devices.

(b) The purpose of the schedule is to provide the contracted items for VA Audiology and Speech Pathology Services at the VA Medical Centers (VAMCs) as a primary source. OGAs, via an Inter-Agency Agreement (IAA) authorized by the VA DLS, may use the contracts as a source.

(c) The objectives of this contract are to:

1. Establish a multiple award contract that can serve the entire United States and its territories for medically prescribed hearing aids and repairs to eligible veteran beneficiaries using standardized ordering processes.

2. Leverage the Department of Veteran Affairs enterprise account to establish favorable pricing for hearing aid services and supplies through cost savings by streamlining internal processes and billing practices in conjunction to current commercial standards.

3. Contracts will be used as a primary source by VHA. Other Government agencies (if authorized by the VA NAC/CSAS), may use the contracts as a source. If authorized, Other Government agencies may procure contract line items as a single purchase order outside of the ROES by directly contacting the Contractor(s).

B.6 SCOPE

(a) The Contractor(s) shall perform services as identified in this Performance Work Statement (PWS). This PWS covers the following types of prescription digital hearing aids:

custom (CHA), behind-the-ear (BTE); and receiver-in-the-canal (RIC). It also includes wireless systems that require a hearing aid in order to function; various types/styles of earmolds; digital wireless CROS transmitters; simple wireless remotes; rechargeable hearing aids; Cochlear Implant and Auditory Osseointegrated Implant compatible devices; primary and secondary features, extra components, programming software and training related to the devices covered within the schedule. Also included in this PWS is hearing aid chargers and repairs to the approved hearing aids that require repair and are out of warranty.

(b) The schedule will result in multiple awards, fixed priced IDIQ contracts for the period of November 1, 2024 through October 31, 2029.

(c) Contracts will be used as a primary source by VA medical facilities. Other

Government agencies, authorized by the VA DLS, may use the contracts as a source. Authorized agencies are as follows: Department of Defense (DoD) and Indian Health Services (IHS). Upon mutual agreement between the Contractors and Government, other Government agencies (OGAs) may be added to the contract by modification.

(d) Hearing aids, wireless systems, earmolds and simple remotes, and hearing aid chargers will be ordered from time to time as such quantities as needed to fill agency requirements in accordance with current applicable supply procedures. Orders will be in accordance with Federal Acquisition Regulation, agency procurement policy and requirements specified within the contract. Items will be for delivery worldwide, f.o.b. destination. The Contractor will be obligated to deliver all items that may be ordered during the term of the contract. There is no expressed or implied guarantee that the quantities will be ordered regularly.

B.7 PRICING

(a) Devices are purchased with a package price for model and components offered with the package.

(b) Changes within the package can be made during the trial period as stated in Section B.13, if applicable (See Section B.13). Changes to a hearing aid, which moves the selection(s) into a different model, would require the difference in price to be charged or credited accordingly.

During the trial period only three (3) changes within a package can be made at no cost.

(c) After the trial period, any extra components must be ordered separately. The extra component pricing shall be used for those changes. There will be no credit issued for components removed from a device. Extra components can only be added during the new device warranty period.

B.8 DELIVERY INFORMATION & SHIPPING INFORMATION

8.1 Delivery for New Custom Prescription Hearing Aids

(a) Delivery is F.O.B. destination, worldwide.

(b) Delivery time frame after receipt of electronic order (ARO) is 10 business days. Any items not received within the agreed period will be considered delinquent and will result in a negative Contractor Performance Assessment Reporting System (CPARS) rating.

(c) Delivery will be to multiple destinations. No orders placed under this contract shall be sent directly to a patient.

(d) Other Government agencies may place their delivery order directly with contractors at the contractual rates, using the ordering procedures outlined in Section B.24. The instruments will be shipped to the facility address on the contractor provided form.

(e) Expedited Delivery. When the contract delivery schedule does not meet the urgent need of the ordering activity, the Government reserves the right to request accelerated deliveries under this contract. In the event the Government desires expedited delivery, the ordering activity shall telephonically contact the contractor and inquire into the feasibility of obtaining accelerated delivery. The contractor shall respond to the inquiry within one (1) business day. If the contractor agrees to an accelerated delivery schedule acceptable to the ordering activity, no additional shipping charges will be incurred as a result of the accelerated delivery.

8.2 Delivery for Hearing Aid Repairs

(a) Delivery is F.O.B destination.

(b) The Government desires delivery to made according to the following schedule:

(1) Desired Delivery Schedule.

(i) Repairs – 5 business days after receipt of electronic order.

(2) Required Delivery Schedule.

(i) Repairs – 10 business days after receipt of electronic order.

(c) Delivery of repaired hearing aid(s) shall be made to the Denver Logistics Service, 555 Corporate Circle, Golden, CO 80401-5621 or the address specified on the authorizing repair transaction. If the expected delivery date falls outside of the 10 business days, the contractor is responsible for additional delivery costs for expedited delivery.

(d) Delivery schedules specified on purchase orders issued against the resulting contract are the dates materials are due in, not the shipping dates. The government must be notified immediately if there are delays anticipated. The government will reserve the right to cancel the order and have the contents returned to the originator for repair through possible other sources.

(e) Expedited Delivery. When the contract delivery schedule does not meet any urgent delivery requirements of the ordering activity, the Government reserves the right to request accelerated deliveries under this contract. In the event the Government desires expedited delivery, the ordering activity shall telephonically contact the Contractor and inquire into the feasibility of obtaining accelerated delivery. The Contractor shall respond to the inquiry within 24 hours. If the Contractor agrees to an accelerated delivery schedule acceptable to the ordering activity, no additional shipping charges will be incurred as a result of the accelerated delivery.

(f) The contractor is responsible for all delivery costs when regular delivery is indicated on the purchase order.

8.3 SHIPPING INFORMATION

(a) Contractor shall provide postage paid shipping to any user of this contract. Contractor shall be responsible for any additional charges that might be incurred due to their carrier.

(b) Hearing aid repairs shall be shipped to the “ship to” address designated on the order or the DLS, 555 Corporate Circle, Golden, CO 80401-5621

(c) Bulk shipments containing multiple repairs shall include an itemized packing list that includes the purchase order number, device serial number, and patient’s last name for each device included in the shipment.

(d) Hearing aids received in sets for repairs shall be shipped in sets as received, to include any and all ancillary items received with the purchase order.

(e) Under no circumstance will the end user of the hearing aid receive direct shipment of repair order. If the Contractor believes the address in the “ship to” section of the purchase order is that of the end user, they should contact the COR by email at dalcadj@va.gov and include the Purchase Order number and make, model and serial number of the hearing aid.

(f) If expedited delivery (B.17(e)) is requested, the government may request that the orders be shipped to the attention of a specific person at a VA clinic or the DLS. This would be in addition to the normal ship-to address indicated on the purchase order and is not meant to change the address except for the single shipment identified.

mailto:dalcadj@va.gov

(g) The packing slip for all shipments shall include:

(1) VA Purchase Order Number

(2) Patient Last Name, last four (4) of the social security number, and date of birth

(DOB)

(3) Vendor Name

(4) Hearing Aid Serial Number

(5) Packaging Multiple Repairs (if applicable)

(6) Total Cost of Purchase Order

(7) All items delivered will adhere to shipping requirements listed above regardless if shipped by contractor or drop-shipped from manufacturer at no additional cost to the

VA.

B. 9 HEARING AID TECHNICAL REQUIREMENTS

9.1. GENERAL

(a) Group 1 CHA, Group 2 BTE , Group 3 RIC , Group 4 Category 1 (Wireless Systems), Group 5 Earmolds, and Group 9 Hearing Aid Chargers are required. In Groups 1-3 at least one category must be offered for each group. Required Groups must be offered or the offer will not be considered. Group 4 Category 2, Group 6, Group 7 and Group 8 are optional All hearing aids in Group 1, Group 2, Group 3 must be compatible with one or more wireless systems in Group 4 Category 1, unless not technologically feasible (i.e. the hearing instrument is too small to accommodate the necessary components for the wireless technology or the requirements of the category (SCIF) precludes it). Note: For the purposes of this solicitation/contract, the term “not technologically feasible” means that a feature is impractical due to physical size of the hearing aid or not consistent with industry standards. “Not technologically feasible” is not due to vendor’s design or marketing decisions.

(b) All hearing aids, wireless systems, wireless FM systems, simple wireless remote controls, and hearing aid chargers shall be serialized.

(c) Any device that requires FDA pre-market (510K) approval shall have such approval at the time of submission to the Government for consideration of award and/or modification(s).

(d) Shipping containers and presentation cases will not include advertising, surveys or questionnaires, cross-selling literature, or insurance offers.

(e) Each device shipment shall include make, model and serial number of the devices included in the shipment when scanned.

(f) Specific group requirements are listed below. Any exceptions will be noted under the group requirements.

(g) All batteries supplied by vendor shall be mercury-free.

(h) Smartphones will not be provided as part of this contract.

9.2. PRESCRIPTION HEARING AIDS

(a) Minimal Technical Requirements for all hearing aid groups and categories (Groups 1- 3):

(1) All hearing aids shall be fully programmable.

(2) Minimum shade/color availability shall be:

(i) Dark brown, medium brown, and beige/light skin tone colors

(ii) Highly Contrasting colors (for example: black and white, black/light grey) for a matching set of hearing aids for use with the dual sensory population.

(3) Sixteen (16) or more channels

(3) Three or more programs

(4) Adaptive directional microphone technology, unless not technologically feasible due to the size of the instrument

(5) Adaptive signal processing.

(6) Noise reduction strategies for steady state and transient noise.

(7) Wireless programmability, unless not technologically feasible due to the size of the instrument

(8) Programs accessible by the user.

(9) Active feedback suppression.

(10) Data logging.

(11) Wireless communication between hearing aids, of a binaural set, unless not technologically feasible due to the size of the instrument

(12) Average total harmonic distortion (THD) calculated by averaging the values measured at 500 Hz, 800 Hz, and 1600 Hz according to the procedures specified in ANSI/ASA S3.22-2014 shall be less than 5%.

(13) Equivalent input noise level measured according to the procedures specified in ANSI/ASA S3.22-2014 shall not exceed 29 dB. For power and super-power instruments, the equivalent input noise level measured according to these procedures shall not exceed 32 dB.

(14) Contractors shall have a range of hearing aids in each group appropriate for mild, moderate, and severe hearing losses. See definition list for definitions of mild, moderate, and severe.

(15) Contractors shall have a minimum of one (1) model in each group which has a matrix at or above an MPO of 125 dB SPL and maximum gain of 60 dB SPL.

(b) The following items (1-5) shall be included in packaging:

(1) Cleaning tool/cloth (at least one).

(2) Soft and hard carrying case.

(3) Literature specific to the enclosed instrument/s and its features.

(4) Packaging list/invoice.

(5) Items that allow the patient to maintain or use the instruments effectively (e.g., cleaning tools, wax prevention kits, replacement ear tips, fixed length slim tubing, phone magnets) and/or educational materials about the hearing instrument provided and/or general information about hearing loss may be provided.

(6) Small tote bags may be included with the device for the patient’s use to carry the device(s), supplies, and literature home.

(7) Items that will assist the clinician in fitting or instructing the patient in the use of the instrument (vent plugs, color chips, various size domes/ear tips, tubing lengths) may be included with the instrument(s).

(c) Up to 8 mercury-free batteries per order may be provided at the vendor’s option.

Non-rechargeable hearing aids in Groups 1-3, 7 and 8 shall be designed to use batteries that are commercially and readily available for acquisition by the DLS from various contractors.

(d) In accordance with current FDA regulatory standards 21 CFR 801.420, hearing aids shall be clearly and permanently marked with the name of manufacturer or distributor, the model name or number, the serial number, and the year of manufacture. A “+” symbol to indicate the positive connection for battery insertion, unless it is physically impossible to insert the battery in the reversed position. It is preferred that serial numbers begin with the year of manufacture.

(e) Contractors shall provide varying sizes of ear tips, domes, or sleeves for optimum fitting options from occluded to open non-occluding design for BTE and RIC hearing aids. These ear tips or inserts do not require ear mold impressions from the audiologists.

(f) Rechargeable hearing aids and hearing aid chargers with onboard rechargeable batteries shall be shipped with the rechargeable battery shall be charged to a minimum of 25% charge but no more than 30% from the vendor so that device can be tested without requiring an initial charge.

(g) Information shall be provided in the hearing aid shipment regarding the battery status of rechargeable hearing aids to include battery life estimates for the hearing aid when on the shelf (i.e. drain rate) and the battery life estimates when amplifying sound and when both amplifying sound and streaming.

9.2.1. GROUP 1 – CUSTOM HEARING AID (CHA) DIGITAL PRODUCTS

(REQUIRED)

(a) Physical Characteristics: For the purpose of this solicitation/contract, the term CHA includes full shell, canal, and completely-in-the-canal (CIC) form factors.

(b) Product Line: At minimum, the contractor shall offer the following form factors: full shell, canal, and CIC. For the purposes of this solicitation/contract, variants of the full shell device (e.g., low profile) shall be considered to be a full shell device. Variants of the canal device (e.g., half shell, mini canal, microphone in helix) shall be considered to be a canal device. Variants of CIC devices (e.g. deep fitting or invisible-in the-canal designs) shall be considered to be a CIC device.

Note: Due to size/technology limitations, CIC devices are exempt from any wireless requirements.

GROUP 1 – CATEGORY 1 – NON-RECHARGEABLE

(a) Additional Minimal Technical Requirements for Group 1-Category 1 CHA Products:

(1) Red/blue is a required shell color

(a) Shells that are made of other than standard material (hypoallergenic material, titanium) are not required to be available

GROUP 1 -CATEGORY 2 – RECHARGEABLE

(a) Additional Minimal Technical Requirements for Group 1-Category 2 CHA Products:

(1) For the purposes of this contract rechargeable power refers to any hearing aid that utilizes a lithium-ion battery that requires an external charging unit.

(2) Red/blue is a required shell color material, titanium) are not required to be available

(b) At least one (1) compatible charger (separately priced) must be available from Group 9.

GROUP 1 -CATEGORY 3 – MULTIPLE CHIPS

(a) Additional Minimal Technical Requirements for Group 1-Category 3 CHA Products:

(1) For the purposes of this contract multiple chips refers to any hearing aid containing two (2) or more separate microchips. The individual microchips may support signal processing, deep learning, machine learning or other emerging technological capabilities that enhance the performance of the hearing aid.

(2) Red/blue is a required shell color material, titanium) are not required to be available.

GROUP 1 -CATEGORY 4 – SENSITIVE COMPARTMENTED INFORMATION

FACILITY (SCIF)

(a) For the purposes of this contract a SCIF compliant hearing aid refers to a device that does not have specific wireless capabilities or can have those capabilities disabled via firmware by the manufacturer or via fitting software by an Audiologist.

(b) Additional Minimal Technical Requirements for Group 1-Category 4 CHA Products:

(1) No hands-free (bi-directional wireless audio transmission) technology. Ability to disable all Bluetooth features is desired when technically feasible.

(2) Restricted features may be disabled in firmware by manufacturer, or through fitting software by the Audiologist. Note: if disabled in firmware by the manufacturer, documentation indicating that wireless features have been disabled will be provided with the devices when shipped.

(3) Disabled restricted features cannot be re-activated by wearer via manual switch, simple remote control or any other wireless control capability such as a smart phone app.

(4) Red/blue is a required shell color (a) Shells that are made of other than standard material (hypoallergenic material, titanium) are not required to be available.

9.2.2. GROUP 2 – BEHIND-THE-EAR (BTE) HEARING AIDS (REQUIRED)

(a) Physical Characteristics: Group 2 includes those instruments whose chassis, which contains the microphone, amplification circuitry and receiver, sits upon and behind the pinna and is coupled to an earmold or ear tip via hollow tubing through which the amplified sound is transmitted.

GROUP 2 - CATEGORY 1 – NON-RECHARGEABLE

(a) Additional Minimal Technical Requirements for Group 2-Category 1 BTE Products:

(1) All power models shall have T-coil capability whether or not such features are ordered, except when not commercially available or not technically feasible.

(b) Contractors shall have a minimum of at least one (1) power and one (1) super-power hearing aid models.

Kruger, Kelli Add same language for additional line items.

Kruger, Kelli Need to define multiple chips

Kruger, Kelli Scott Forbes: The hearing aids should have a user accessible program in which the capability to stream to or from other wireless devices be disabled. This could be accomplished by having a preset program selection (e.g. labeled “Non-Wireless”) in the software or by giving the dispensing Audiologist the ability to deactivate those capabilities within any program. This capability would not need to disable the wireless communication between two hearing aids of the same set.

The hearing aids would need to have an on-board push button or toggle switch that would allow the user to access the non-wireless program while in a secure compartmented information facility (SCIF). There is no requirement that an external indicator of wireless capability status be present. In fact, anything that might identify a wearer as someone who works within a SCIF is to be avoided.

The DOD team requested a software alert anytime an attempt is made to eliminate (delete) the non-wireless program. I did not include that request because I think it should fall to the wearer to ensure the capability in present at any given time. If the user can be trusted to make sure the aids are in non-wireless mode when entering a SCIF, the user can be responsible for ensuring the capability remains anytime the aids are reprogrammed. That should be part of the counseling provided by the dispensing Audiologist.

GROUP 2 -CATEGORY 2 – RECHARGEABLE

(a) Additional Minimal Technical Requirements for Group 2-Category 2 BTE Products:

(1) For the purposes of this contract rechargeable power refers to any hearing aid that utilizes a lithium ion battery or solid-state battery that requires an external charging unit.

(b) Contractors must ship the charging unit with hearing aids, not in a separate shipment.

GROUP 2 -CATEGORY 3 – MULTIPLE CHIPS

(a) Additional Minimal Technical Requirements for Group 2-Category 3 BTE Products:

(1) For the purposes of this contract multiple chips refers to any hearing aid containing two (2) or more separate microchips. The individual microchips may support signal processing, deep learning, machine learning or other emerging technological capabilities that enhance the performance of the hearing aid.

(2) Red/blue is a required shell color

GROUP 2 -CATEGORY 4 – SENSITIVE COMPARTMENTED INFORMATION

(a) For the purposes of this contract a SCIF compliant hearing aid refers to a device that does not have specific wireless capabilities or can have those capabilities disabled via firmware by the manufacturer or via fitting software by an Audiologist.

(b) Additional Minimal Technical Requirements for Group 2 – Category 4 BTE Products:

(1) No hands-free (bi-directional wireless audio transmission) technology. Ability to disable all Bluetooth features is desired when technically feasible.

(2) Restricted features may be disabled in firmware by manufacturer, or through fitting software by the Audiologist. Note: if disabled in firmware by the manufacturer, documentation indicating that wireless features have been disabled will be provided with the devices when shipped.

(3) Disabled restricted features cannot be re-activated by the wearer via manual switch, simple remote control or any other wireless control capability such as a smart phone app.

9.2.3. GROUP 3 – RECEIVER-IN-THE-CANAL (RIC) (REQUIRED)

(a) Physical Characteristics: For the purpose of this contract, RIC hearing aids include any free form instrument where the receiver of the hearing aid is located in the patient’s ear canal. The remaining chassis of the hearing aid may be located above or behind the pinna of the patient.

GROUP 3 - CATEGORY 1 – NON-RECHARGEABLE

(a) Minimal Technical Requirements for Group 3-Category 1 RIC Products:

(1) Must utilize the NOAH Link wireless programmer

GROUP 3 - CATEGORY 2 – RECHARGEABLE

(a) Minimal Technical Requirements for Group 3-Category 2 RIC Products:

(1) For the purposes of this contract rechargeable power refers to any hearing aid that utilizes a lithium-ion battery or solid-state battery that requires an external charging unit.

(2) Must utilize the NOAH Link wireless programmer

(b) Contractors must ship the charging unit with hearing aids, not in a separate shipment.

GROUP 3 - CATEGORY 3 – MULTIPLE CHIPS

(a) Minimal Technical Requirements for Group 3-Category 3 RIC Products:

(1) For the purposes of this contract multiple chips refers to any hearing aid containing two (2) or more separate microchips. The individual microchips may support signal processing, deep learning, machine learning or other emerging technological capabilities that enhance the performance of the hearing aid.

(2) Red/blue is a required shell color

(a) Shells that are made of other than standard material (hypoallergenic

(3) Must utilize the NOAH Link wireless programmer

GROUP 3 - CATEGORY 4 – SENSITIVE COMPARTMENTED INFORMATION

(a) For the purposes of this contract a SCIF compliant hearing aid refers to a device that does not have specific wireless capabilities or can have those capabilities disabled via firmware by the manufacturer or via fitting software by an Audiologist.

(b) Minimum Technical Requirements for Group 3-Category 4 RIC Products:

(1) No hands-free (bi-directional wireless audio transmission) technology. Ability to disable all Bluetooth features is desired when technically feasible.

(2) Restricted features may be disabled in firmware by manufacturer, or through fitting software by the Audiologist. Note: if disabled in firmware by the manufacturer, documentation indicating that wireless features have been disabled will be provided with the devices when shipped.

(3) Disabled restricted features cannot be re-activated by wearer via manual switch, simple remote control or any other wireless control capability such as a smart phone app.

(4) Must utilize the NOAH Link wireless programmer.

GROUP 3 – CATEGORY 5 – ADVANCED RECEIVERS

(a) Minimal Technical Requirements for Group 3-Category 5 RIC Products:

(1) For the purposes of this contract, an advanced receiver shall:

a. Include compatible hearing aid that may or may not have been submitted in another category in Group 3.

b. Provide the same/similar acoustic functionality as a standard receiver

c. Provide additional, technological functionality not otherwise provided by the hearing aid on its own

i. This technology must be housed within the receiver

ii. This technology may improve the acoustic/auditory function of the hearing aid or provide other health/fitness related features.

1. Examples include health/fitness tracking, motion/fall detection, heart rate monitoring.

9.2.4. GROUP 4 – WIRELESS SYSTEMS (REQUIRED)

GROUP 4 - CATEGORY 1 – WIRELESS SYSTEMS (REQUIRED)

(a) For the purpose of this contract, wireless systems include transmitters, adaptors, interfaces, and receivers designed to function with the vendor’s hearing aids as an integrated system to optimize communication in various listening environments and interface various devices such as TV, telephones, and computers to the hearing aids.

Wireless systems contain single or multi-frequency wireless devices that interface with hearing aids and have one or more transmitter options. Contractor shall provide a user guide for each device whenever available.

(b) All hearing aids in Groups 1-3 shall be compatible with one or more wireless systems in this group; unless not technologically feasible (i.e. the hearing instrument is too small to accommodate the necessary components for the wireless technology or the requirements of the category (SCIF) precludes it).

(c) Wireless systems do NOT include the following device categories:

(1) “Dedicated” wireless CROS transmitters.

(2) Wireless assistive listening devices (ALD).

(3) Wireless hearing aid programming devices.

(4) Wireless simple remote controls for hearing aids (see Group 6).

(d) There is no cap on the number of systems that may be offered in the Group.

GROUP 4 CATEGORY 2 – WIRELESS FM SYSTEMS (OPTIONAL)

(a) If a contractor offers wireless FM, they must also offer one or more systems in Group 4, Category 1.

(b) Wireless FM Systems include universal or integrated receivers and wireless FM transmitters. Transmitters must include the following:

(1) Inputs for other devices such as TV, stereo, PC or external microphone.

Dedicated wireless FM microphone transmitters are exempt from this requirement.

(2) Include charger unit, rechargeable battery or power cord/transformer (if required) for transmitter.

9.2.5. GROUP 5 – EARMOLDS (REQUIRED)

(a) For the purposes of this contract an earmold is any item that is manufactured from an earmold impression or an ear scan (STL file) that is coupled to a hearing aid and shall be offered within Group 2, Group 3, Group 7 and Group 8 model packages, if applicable.

(b) When part of the initial order, Contractors shall ship the earmold with the hearing aid, not in separate shipments.

(c) An earmold may be procured at the time of the initial order, subsequent to an initial order where an earmold was not ordered (e.g. ordering an occluding earmold for a BTE initially ordered with an open fitting), or as a replacement for an existing earmold.

(d) An earmold may be ordered from a contractor for any make or model of hearing aid currently or previously offered in Groups 2, Group 3, Group 7 or Group 8 of the manufacturer’s contract. Earmolds may be ordered for traditional BTE hearing aids of any make or model, regardless of whether they were purchased from another manufacturer’s contract, self-purchased by the patient, or procured from other Government agencies.

(e) Earmolds are a Primary Feature under Components when procured with the initial hearing aid order or during the 180-day trial period, when ordered from the original hearing aid manufacturer. Only one set of earmolds ordered during the trial period shall be provided at no charge. The commercial name on the contract “Publication Sheets” will identify the type of earmold. All selectable earmold features such as the types of materials or colors may be noted within the data file in one of the Secondary Feature categories.

(f) Minimum Technical Requirements for Group 5 Earmolds:

(1) Earmolds shall have R/L demarcations that are defaulted to the red/blue dot, respectively, unless deselected in the order by the VA Audiologist.

(2) Styles. The contractor shall provide a minimum of the following styles.

Additional styles may be offered.

(i) Standard (Full Shell)

(ii) Skeleton

(iii) Canal

(iv) Shell (Half Shell)

(v) Non-occluding

(3) Materials. The contractor shall provide a minimum of the following materials. Additional materials may be offered.

(i) Acrylic

(ii) Silicone

(4) Colors. The contractor shall provide a minimum of the following colors:

clear, tan, pink, light brown, medium brown, and dark brown. Additional colors may be offered. Colors may not be available in all materials.

(5) Venting Options. The following venting options shall be provided. Additional venting options may be offered.

(i) Pressure (approx. 1 mm)

(ii) Small

(iii) Standard (approx. 1.6 mm)

(iv) Selectable vent (e.g. SAV)

(6) Tubing Options. The contractor shall provide a range of tubing sizes, thicknesses, and colors.

Standard NAEL Tubing Sizes Size/Type Inside Diameter Outside Diameter 9 2.4mm 4.1mm

12 2.2mm 3.2mm 13 Standard 1.9mm 2.9mm 13 Medium 1.9mm 3.2mm 13 Thick Wall 1.9mm 3.3mm 13 Double Wall 1.9mm 3.6mm 14 1.7mm 2.9mm 15 1.5mm 2.9mm 16 Standard 1.3mm 2.9mm 16 Standard 1.3mm 2.9mm 16 Thin 1.3mm 2.2mm

(g) Should an earmold be purchased under this contract for use with another hearing aid procured under a separate VA National Hearing Aid Program contract, the contractor shall be reimbursed at the contract specified rate.

9.2.6. GROUP 6 – SIMPLE REMOTE CONTROLS (OPTIONAL)

(a) Simple remote controls are those devices that wirelessly communicate with hearing aids in order to control the instruments’ function. Simple remote controls are able to adjust volume and/or program settings of an instrument. These devices may control two hearing instruments of a binaural set jointly (i.e., same command function is sent to both instruments simultaneously) or control each hearing instrument independently. They may also have the ability to switch between joint and independent instrument control.

(b) The contractor must indicate which hearing aids are compatible with which remote controls.

(c) Remote controls that also have the capability of receiving and transmitting acoustic information to and from telephones or other devices shall be classified as Group 4 Category 1.

(d) Simple Wireless Remote Controls shall contain the following minimum characteristics:

(1) Power source shall be rechargeable, long-life or commercially available batteries.

(2) Control buttons shall be clearly marked for user identification of function and be raised or have sufficient tactile difference to allow for identification of its function.

(3) Be compatible with hearing aid devices in Groups 1, 2, and/or 3.

9.2.7. GROUP 7 – CROS TRANSMITTERS (OPTIONAL)

GROUP 7 – CATEGORY 1 – NON-RECHARGEABLE (OPTIONAL)

(a) For the purposes of this contract a CROS transmitter refers to a device designed to route a wireless signal to a digital hearing aid. The system may be compatible with wireless accessories. The combination of transmitter and hearing aid may be in any CHA form factor, BTE, and RIC combination.

(b) In order to be considered for this Group, contractors must have devices in all the required Groups [Group 1 Category 1 (CHA Non-Rechargeable), Group 2 Category 1 (BTE Non-Rechargeable), Group 3 Category 1 (RIC Non-Rechargeable), Group 3 Category 2 (RIC-Rechargeable), Group 4 Category 1 (Wireless Systems), and Group 5 (Earmolds)].

(c) There is no cap on the number of systems that may be offered in this category.

GROUP 7 – CATEGORY 2 – RECHARGEABLE (OPTIONAL)

(a) For the purposes of this contract rechargeable power refers to any hearing aid that utilizes a lithium-ion battery or solid-state battery that requires an external charging unit.

(b) For the purposes of this contract a CROS transmitter refers to a device designed to route a wireless signal to a digital hearing aid. The system may be compatible with wireless accessories. The combination of transmitter and hearing aid may be in any CHA form factor, BTE, and RIC combination.

(c) In order to be considered for this Group, contractors must have devices in all the required Groups [Group 1 Category 1 (CHA Non-Rechargeable), Group 2 Category 1 (BTE Non-Rechargeable), Group 3 Category 1 (RIC Non-Rechargeable), Group 3 Category 2 (RIC-Rechargeable), Group 4 Category 1 (Wireless Systems), and Group 5 (Earmolds)].

(d) There is no cap on the number of systems that may be offered in this category.

9.2.8. GROUP 8 – COMPATIBLE DEVICES (OPTIONAL)

For the purposes of this contract a Cochlear Implant (CI) Compatible Device or Auditory Osseointegrated Implant (AOI) Compatible Device refers to a device designed to wirelessly communicate with a CI processor. In order to be considered for this Group, contractors must have devices in all the required Groups [Group 1 Category 1 (CHA Non-Rechargeable), Group 2 Category 1 (BTE Non-Rechargeable), Group 3 Category 1 (RIC Non-Rechargeable), Group 3 Category 2 (RIC-Rechargeable), Group 4 Category 1 (Wireless Systems), and Group 5 (Earmolds)]. A device offered in another Group cannot be included in this Group.

GROUP 8 - CATEGORY 1 – HEARING AIDS (OPTIONAL)

(a) For the purposes of this contract a CI Compatible Hearing Aid or an AOI Compatible

Hearing Aid is a hearing aid that wirelessly communicates a signal to a CI or AOI processor. The hearing aid may be compatible with wireless accessories and may be offered in any CHA, BTE or RIC form factor.

(b) There is no cap on the number of systems that may be offered in this Category.

GROUP 8 - CATEGORY 2 – WIRELESS SYSTEMS (OPTIONAL)

(a) For the purposes of this contract a CI or AOI Compatible Wireless System refers to an accessory that communicates a signal to a CI or AOI processor wirelessly or via direct auditory input.

(b) There is no cap on the number of systems that may be offered in this Category.

9.2.9. GROUP 9 – HEARING AID CHARGERS

(a) For the purposes of this contract a Hearing Aid Charger refers to a device that are compatible with rechargeable hearing aids in groups 1-3, group 7, or group 8.

(b) Minimal Technical Requirements for Group 9 Hearing Aid Charger Products:

(1) External charging unit that charges the lithium-ion battery of a rechargeable hearing aid

(2) Must be compatible with one or…