ATTACHMENT B TECHNICAL REQUIREMENTS (SALIENT CHARACTERISTICS) (AOI).docx

The Department of Veterans Affairs National Acquisition Center, Commodities and Services Acquisition Service, Denver Logistics Center

AOI SOLCITITATION NO. 36C79120R0006

ATTACHMENT B

Minimum Technical Requirements (Salient Characteristics) The contractor shall provide and deliver an FDA Device Registered (FDA 21 CFR 874.3375) AOI that meets or exceeds each of the technical requirements (salient characteristics) listed in this Attachment B:

DEVICES/SYSTEMS/KITS

AUDITORY OSSEOINTEGRATED IMPLANT SYSTEMS (CLIN 01)

The System must be hearing systems that provide an auditory signal through bone conduction. Each system must:

a) consist of three components:

i. Auditory Osseointegrated Implant that is permanently affixed to the skull (typically mastoid bone).

ii. Abutment (ALT I) and/or Magnetic Plate (ALT II), or other magnetic connection that is affixed to the implant and allows transmission of sound/vibration to the implant.

iii. Sound Processor that is reversibly attached to the Abutment or magnetic connection.

· b) meet or exceed all minimum requirements for AOI listed in CLIN 02 and Sound Processors listed in CLIN 05 below. If Abutment and Magnetic Plate are offered meet or exceed all minimum requirements in CLIN 04 below.

AUDITORY OSSEOINTEGRATED IMPLANTS ONLY (CLIN 02)

AOI must be hearing devices that provide an auditory signal through bone conduction and are permanently affixed to the skull (typically mastoid bone). Each AOI must:

a. be biocompatible with demonstrated osseointegration,

b. range from 3-4 mm to accommodate varying skull thickness

AUDITORY OSSEOINTEGRATED IMPLANT WITH ABUTMENT (ALT I) OR MAGNETIC PLATE KIT (ALT II) (CLIN 03) AOI must meet or exceed all minimum requirements for AOI listed in CLIN 02 above and Abutment and/or Magnetic Plate listed in and CLIN 04 below.

ABUTMENT (ALT I) OR MAGNETIC PLATE (ALT II) (CLIN 04)

a. If Abutment is utilized, it must exchange to an alternate length or configuration of abutment without the need of removal of implant (e.g.: transcutaneous to percutaneous or longer abutment), or to perform the procedure in a two-stage fashion (placement of sleeper implants). The required length must be from 6 mm - 14 mm to accommodate wide range of scalp thickness.

b. If a Magnetic Plate is utilized, it must have the capability of being removed and be exchanged with Abutment.

SOUND PROCESSOR KIT (CLIN 05):

Must have:

a. At least three (3) Programs

b. Microphones: Directional or omni-directional

c. Minimum output frequency range of 250-7000 Hz

d. Total harmonic distortion below 3% above 600 Hz

e. Program control- accessible by the user through onboard control, remote control or phone application.

f. Volume control- accessible by the user through onboard control, remote control or phone app

g. Indicators for low battery, program change, and volume change, visible and/or audible indicators for low battery etc.

h. Feedback management system

i. Must have at least one model with onboard wireless connectivity independent of DAI to:

· Programming hardware

· Remote control

· Assistive devices

j. Must have at least one model with the ability to connect to a headband provided by the vendor

k. Kit must include sound processor with an option for actuator (if needed) or magnetic connection (if needed)

ACCESSORIES

ACCESSORIES FOR AUDITORY OSSEOINTEGRATED IMPLANTS (OPTIONAL SUB-CLIN 02.01)

Please list all available accessories that are necessary for AOI (offered under CLIN 02 above) to function properly and/or to enhance the AOI function.

ACCESSORIES FOR ABUTMENT (ALT I) AND/OR MAGNETIC PLATE (ALT II) (OPTIONAL SUB-CLIN 04.01) Please list all available accessories that are necessary for Abutment or Magnetic Plate (offered under CLIN 04) to function properly and/or to enhance their function.

ACCESSORIESAND FOR SOUND PROCESSOR – HEADBAND (SUB-CLIN 05.01)

Headband must be:

a. Adjustable

b. Latex-free

c. Connect to offered Sound Processor

ACCESSORIESAND FOR SOUND PROCESSOR – OTHER THAN HEADBAND (OPTIONAL

SUB-CLIN 05.02)

Please list all available accessories that are necessary for Sound Processor (offered under CLIN 05 above) to function properly and/or to enhance the function of Sound Processor, other than Headband.

REPLACEMENT PARTS

REPLACEMENT PARTS FOR AUDITORY OSSEOINTEGRATED IMPLANTS (OPTIONAL SUB-CLIN 02.02) Please list all replacement parts available for AOI (offered under CLIN 02 above).

REPLACEMENT PARTS FOR ABUTMENT (ALIT I) AND/OR MAGNETIC PLATE (ALT II) (OPTIONAL SUB-CLIN. 04.02 Please list all available replacement parts for Abutment and/or Magnetic Plate (offered under CLIN 04).

REPLACEMENT PARTS FOR SOUND PROCESSOR – OTHER THAN HEADBANDS (OPTIONAL SUB-CLIN 05.03) Please list all available replacement parts for Sound Processor (offered under CLIN 05 above).