Attachment 1 - Questions for Industry.xlsx

XLSX spreadsheet 30 KB Posted Jul 15, 2025

Attached to: 6515--Request for Information for Audio Osseointegrated Implants/ Cochlear Implants NAICS 339113
Solicitation number: 36C79125Q0025
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 19

About this file

Written by GovTribe AI · Jul 15, 2025

This document is a Request for Information (RFI) from the Department of Veterans Affairs (VA) National Acquisition Office seeking comprehensive market research on Auditory Hearing Implants, specifically Cochlear Implants (CI) and Audio Osseointegrated Implants (AOI). The RFI includes an extensive Excel workbook with nine detailed questionnaire sections covering topics such as business structure, supply chain, FDA standards, commercial practices, technical device capabilities, wireless connectivity, IT data and software components, and process improvement opportunities. Vendors are required to submit comprehensive responses electronically to VACSASTEAMA@va.gov by August 11, 2025, with a focus on understanding industry capabilities, manufacturing practices, technological innovations, and compliance with federal regulations.

The solicitation (Number 36C79125Q0025) is categorized under NAICS code 339113 for Surgical Appliance and Supplies Manufacturing, and is specifically preparing for a future recompete of VA's Audio Osseointegrated Implants and Cochlear Implants contract. A joint industry meeting is tentatively scheduled for October 2025 at the Denver Logistic Center in Golden, Colorado. The VA emphasizes that this RFI is solely for market research purposes, does not constitute a formal solicitation, and will not result in an immediate contract award. Interested parties are encouraged to RSVP for potential industry day meetings by contacting Bryan.Crist@va.gov and VACSASTEAMA@va.gov.

View the file

Other files

File	Type	Posted
Auditory Implants -CIs_AOIs-Minimum Technical Requirements 07152025.pdf	PDF	Jul 15, 2025
36C79125Q0025_1.docx	DOCX document	Jul 15, 2025

On GovTribe

Work with this file

Download the original file
Contacts named in this file
Similar government files
Ask GovTribe AI about this file

Try for free Login

Text version

The file's text, extracted by GovTribe without its formatting.

Introduction

Hearing Implant -Request for Information

The Department of Veteran Affairs, National Acquisition Office (NAC), Commodities, Services, and Acquisition Services (CSAS) in conjunction with Veteran Health Administration (VHA), Prosthetic Sensory Aid Services (PSAS), is issuing a Request for Information and Sources Sought Announcement for the Auditory Hearing Implants. Please fill out workbook in its entirity and send back to: VACSASTEAMA@va.gov Subject: RFI # _ Auditory Implant Industry Response

Responding parties should take additional precautionary measures to prevent proprietary information from disclosure by marking the documentation being submitted with labeling sensitivities such as confidential and proprietary. Information provided in response to this RFI and future RFI’s that is marked as proprietary will be handled accordingly.

In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Submittals will not be returned to the responder.

Instructions for filling out workbook:

1. Please fill out each tab in accordance to structure set forth. A column has been provided for the answers, please keep formatting as establsihed and used Arial 12 point font.

Overview of Questions

Question 1 : Business Structure and Industry Alignement

Question 2: Supply Chain

Question 3: Company Philosphy and Future Focus

Question 4: FDA and ISO Standards

Question 5: Company Commerical Practices

Question 6: Device Technical Capabilities, Components, Accessories and other

Question 7: Wireless or Bluetooth Connectivity

Question 8: IT Data, Software and or technical questions

Question 9: Process improvement and modernization efforts in acquistion and finance.

Company Info Company Name Address City State Zip Company UEI Cage Code

Point of Contact Name Title Phone Email

	Question	Answer
1	Please explain your company’s position in the marketplace in regard to the Cochlear Implant (CI) and or Audio Osseointegrated Implants (AOI).
a.	Please explain your parent – subsidiary relationship in regard to the Hearing Implant Industry.
b.	Do you subcontract? If so explain the nature of subcontracts.
c.	In the Auditory Implant Industry are you considered a Contract Manufacturer, Manufacturer, Distributor, Foreign Exporter Repackage/ Relabeled?
d.	How many individuals do you currently employ?
e.	Are you considered a Small Business through Small Business Administration? What is your Socio-Economic Indicator (WSOB, HubZone, 8a, SDVOSB, VOSB) if defined as a Small Business? Are you registered and certified trhough Small Business Administration?
f.	Of the sellers, what is your market share?
g.	Do you see the industry shrinking or growing? The number of buyers and suppliers scarce or plentiful? What is the downstream affect?
h.	What do you see the other buyers doing in their buying practices?
i.	Does your supply exceed demand or vice versa?
j.	What influences does the United States Federal Government as a buyer have on supply and demand?
k.	What are the economic trends that have an impact on the products and or services, including its raw materials or major components? What is the future projection?
l.	How do sustainability requirements impact products and or services?
m.	Are there insolvency issues among sellers and suppliers?
n.	Is there litigation pending that affect the broad market or key sellers?
o.	Is the industry regulated? If so at what levels?
p.	Are there other foreign influences on the industry the United States should be aware of?
q.	Are there impacts from Tarriffs? Please explain.

	Question	Answer
2	Supply chain disruptions in the production of products and or services, to include information technology disruptions (i.e. software compatibility, cybersecurity).
a.	Are there warning signs that disruptions can occur in the supply of raw materials?
b.	Where do you source your supplies to manufacture the product from? Where do the raw materials or components come from? Who provides the raw materials and or major components and what is the market share for each?
c.	How many suppliers exist in the raw material or component supply chain? Are there any United States suppliers?
d.	What risks are inherent to the supply of raw materials? Are there any supply chain constraints VA needs to be aware of? (Think about environmental as well infrastructure.)
e.	How does geography impact the product and or service?
f.	Can your supply chain support a large-scale implementation (i.e., greater than 1,000,000 concurrent patient users nationwide)?
g.	Disruption in Information Technology and software development?
h.	What is the primary location of manufacturing?
i.	Do you foresee any shipping disruptions?

	Question	Answer
3	What is the company philosophy and technology focus for Implants?
a.	What is the next iteration of product lines and services?
b.	Where do you see industry in the next 5 to 10 years?
c.	How quickly is this industry changing?
d.	How are you using Artificial Intelligence in your business model? Are you using AI for data collection from patients, or other? Please explain

	Question	Answer for CI	Answer for AOI
4	Please explain your FDA status for both Cochlear Implant (CI) and or Audio Osseointegrated Implants (AOI). If you produce both, please answer for both CI and AOI.
a.	What is your FDA registrations status for 2025 for AOI and CI?
b.	What is your FDA Registration Number for AOI and CI?
c.	What is your FDA Product Code (s)? Please list all that apply.
d.	What is your FDA clearance approval/class for candidates of devices?
e.	What is considered a hard failure and when is recall triggered?
f.	What is considdered a soft failure? Is a replacement internal covered?
g.	What is the manufacturing faciilities ISO certification and standard?
h.	Can you product be branded or white labled? Is this something you have done for other healthcare customers? Please explain.

		Question	Answer fo CI	Answer fo AOI
	5	What is the company’s commercial practices for Cochlear Implants (CI) and or Audio Osseointegrated Implants (AOI). If you produce both, please answer for both CI and AOI.
	a.	How does the commercial market order from your business, please explain the process.
	b.	Explain and identify what is a priced component and a no cost component.
	c.	Can you price for individual items?
	d.	How do you price for surigcal kits.
	e.	Please provide a product catalog with commercial pricing and Manufacture Suggested Retail Price.
	f.	What is provided as a package with the implant (what is included)?
	g.	What are your commercial standard delivery time frames?
	h.	What are your current shipping rates for United States, Territories and OCONUS locations?
	i.	What is the commercial standard practice for trial periods?
	j.	What is the commercial standard warranty for the products?
	k.	What is the commercial standard for loss and damage?
	l.	What is the definition of damage beyond repair?
	m.	How do you handle product recall?
	n.	What is covered under commercial warranty? What isnt and why?
	o.	What is the commercial warranty period for new devices and when does it begin?
	p.	Do you offer repairs to devices? What kind of repairs are completed? How do you price for repairs?
	q.	What is commercial warranty period for devices after repairs and when does it begin?
	r.	Do you offer trial periods for devices?
	s.	What is the manufacturing coountry of origin for devices?
	t.	What customer service do you provide for clinical staff and patients? Do you have dedicated Government Service Specialist (VA and DoD)?
a.	What are the methods of contact?
b.	What are the hours of operation?
c.	What device programming support is offered?
d.	Are there remote programming opportunities?
	u.	Do you provide government only trainings? What type of education do you offer to VA Clinical staff and or patient? a. Do you have dedicated trainings for upcoming product release? b. When do you provide training for products that are FDA approved? How soon?
	v.	Can you provide shipping of devices/accessories/equipment to all 50 states, US Terrirotries and OCONUS installations? Are there any restrictions or concerns with shipping OCONUS?
	w.	When a service request is initiated for a bad processor, what is the Return Merchandising Authoration process? Is there a difference between CI and AOI, please explain? What comes with the RMA process (Shipping materials, label)?

	Question	Specific to CI	Answer for CI	Specific to AOI	Answer for AOI
6	What are your current product lines and or systems offered? Please identify all the areas required for a complete package and or kit(end user components).
	a.	What are your implant options?		What are your implant options?
	b.	What are the Hearing Aid options for hybrid fitting patients? For the matching HA on the other ear and or retention purposes.		Please describe abutment or magnetic plates offered.
	c.	Are the products battery operated and or rechargeable option?		Are the products battery operated and or rechargeable option?
	d.	Please describe the sound processer:

i. How many program controls? Describe each program control.

ii. How many microphones? Are they directional?

iii. Explain volume control feature. iv. Explain Feedback management system.

v. Programming hardware?

vi. Remotes?

vii. Assistive devices?

viii. Explain low battery notifications and or indicators.

ix. Explain alternative input.

x. Explain volume control feature.

xi. Programming hardware?

xii. Remote Control?

xiii. Accessories? xiv. Explain low battery notifications and or indicators

xv. Explain alternative input (direct audio input).

xvi. What is your stimulation rate per second for electrode array? xvii. What are the Signal Processing Strategies? xviii.Do you provide interoperative equipment and software for sites with operating rooms? Please explain. Please describe the sound processer:

i. How many program controls? Describe each program control.

ii. How many microphones? A. Are they directional? Please explain. B. What is the output frequency? C. What is the total harmonic distortion range? iii. Explain the volumn control feature. iv Explain the feedback management system (Active or Passive). v. Is there programming hardware? vi. Remote control? vii. Accessories? viii. Explain low battery notifications and indicators? ix. Explain alternative input (direct audio input).

e.	What ancillary items/retention devices should be considered (i.e. Headband, Non Surgical Options)?	What ancillary items/retention devices should be considered (i.e. Headband, Non Surgical Options)?
f.	What is the universal programming capability?	What is the universal programming capability?
g.	Telecoil	Telecoil
h.	What comes in a surgical kit, and is it disposable or does it need to be returned?	What comes in a surgical kit, and is it disposable or does it need to be returned?
i.	What do you provide in the OR to test equipment and software?	What do you provide in the OR to test equipment and software?

		Question	Answer for CI	Answer for AOI
	7	Describe the Wireless/Blue Tooth Connectivity(AOI & CI)/ Acoustic devices(CI)
	a.	Is it between the sound processor and hearing aid?
	b.	Is it between hearing aids and wireless accessories?
	c.	Is it between hearing aids, and other technology? (Smartwatch, smart TV, etc.)
	d.	Is there compatibility with different styles of hearing aid (i.e. RIC as well as BTE)?
	e.	Can they make accessories automatic vs manually activated?
	f.	What wireless activity happens between the CI and HA?
	g.	Connectivity of wireless technologies?
	h.	Interactions with other devices?
	i.	What is the Bluetooth Low Energy capability for the product?
	j.	Please explain your implant technology and its Bluetooth compatibility.
i.	What devices can it connect to?
ii.	Is the device Bluetooth compatible with Aura Cast?
iii.	Can device accept direct streaming to one processor with majority of mobile devices and or applications? Please list and explain.
iv.	What is the lifespan of the device?
	k.	What are the software requirements for device in both programming and monitoring?
	l.	Are there any smart phone applications or web applications this device utilizes?

		Question	Answer for CI	Answer for AOI
	6	Please explain the IT data, software and technical components associated with your products.
	a.	Can you support a silent or unattended installation without activation or license keys?
	b.	Remote programming capability for either AOI or CI?
1.	Is a separate app required
2.	Is it synchronous or asynchronous
3.	Is it available on current software version
4.	Are all programming features available as with an in-person appointment?
5.	What verification is available remotely?
	c.	Are you moving towards IPV6 or compatible? If so, what date would you be active?
	d.	Due to Federal Information Security Management Modernization Act (FISMA), the Department of Veteran Affairs is advising vendors of the Federal Risk and Authorization Management Program (FedRAMP) in approach to security, monitoring of information technology for software, and cloud products. To learn more please visit www.fedramp.gov .
a.	Are you FedRAMP compliant in software and or remote programming?
b.	Do you follow the National Institute Standards and Technology (NIST) FIPS publications? If so please annotate which standards you follow.
	e.	The Hearing Instrument Manufacturers’ Software Association (HIMSA) has the objective of developing, marketing and supporting Noah – one standard for integrated hearing care software. How do your devices and software align with NOAH compatibility? Does your software meet HIMSA?
	f.	Many of our veteran’s work in industries or facilities that are Secure Compartmentalized Information Facility (SCIF) rated to keep confidential and proprietary information safe. SCIFs are approved areas that can protect, process, and potentially store sensitive classified information and/or materials. Per the Defense Information Systems Agency (DISA), there should be no Wi-Fi, Bluetooth, cellular, image capturing, video recording, or audio recording capabilities on wearable devices in the SCIF.

Please identify how your technology uses Wi-Fi &Bluetooth technology and how it can be disabled appropriately. Do you have any products approved by DISA to be allowed in SCIF? What information is stated on the technical product details that notify a veteran if they have technology that is Wi-Fi/blue tooth enabled and how to disable it?

	g.	How often can software be submitted to VA due to updates?
	h.	What type of data is collected or accessed from device programming/software of patient?
i.	Does this data include health information?
ii.	Is the health information de-identified under HIPAA Privacy Rule of Safe Harbor or Expert?
iii.	Does the device collect and store data?
iv.	Is the data or information collected or accessed PII on patients?
v.	What type of PII is included?
	k.	How does your solution transmit data and what kind of connectedness is required?
i.	Is the data that is transmitted HIPAA Compliant?
ii.	Is data collected intellectual property?
iii.	What aspects of the technology considered intellectual property?
	l.	Is there an associated mobile or web app? Can you control your apps so that a username and password are not required?
	m.	Is your software Windows 11 compatible? If not when do you expect it to be compatible?
	n.	Please provide a copy of the End User License Agreement (EULA) for applications/software for end users.
	o.	Please disclose your work towards post quantum cryptographic standards. To include how you are ensuring your digital networks are secured ahead of potential fault-tolerant quantum computing. How will your company uphold PQC standards and embedded during technological refreshes and lifecycle updates, cloud migration and other software changes.

	Question	Answer
9	Questions for process improvement and modernization efforts for Acquistions and Finance:
a.	Can your company provide manuals and other materials in accordance to the Rehabilitation Act Amendments of 1998, Section 508 compliance?
b.	If you are a current awardee for the Veteran Affairs Hearing Aid contract, are there any recommendations for changes within the contract? Please explain reasoning for the change. Are there any reporting requirements you would like to see in the new contracts?

c.	Is the language of the contract in any way exclusionary to other technology available in your commercial portfolios today, or in any way inhibitory to anticipated technological advancements in the near future?
d.	Is doing business under the provisions of the current contract burdensome in ways that you view to be unnecessary or counterproductive? Is there potential to reduce costs to the federal government if such unnecessary or counterproductive requirements are revised or eliminated?
e.	Vendors will be required to utilize ANSI X.12 EDI (Electronic Data Interchange) transaction sets for exchange of purchase orders/amendments and invoices with VA. Please describe your existing or planned capabilities for use of the X.12 EDI standard.

File details come from the government source that posted it. Updated Jul 15, 2025.