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Development of an AMF Orion/Blackrock HD-USEA based 60/128 channel implantable wireless simulator system for human auditory nerve implants

Award Number: R44DC018757
ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2020
PERIOD OF PERFORMANCE END DATE: 07/31/2024

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Development of an AMF Orion/Blackrock HD-USEA based 60/128 channel implantable wireless simulator system for human auditory nerve implants - Abstract The development of implantable high channel electronics interfacing with the central and peripheral nervous system has been a continuing effort for decades covering a wide range of applications. Reliable and clinically proven high channel solutions with hermetic encapsulation of the electronics that would be suitable for the use in a Cochlear or auditory nerve have so far not been demonstrated. The project aims to develop and translate a novel clinical high (60-128) channel implantable programmable stimulator (IPS) for use in Cochlear (CI) and auditory nerve (ANI) implants to expand the useable parameter space (electrode count, tonal range, lower stimulation threshold) far beyond current limits. In this project we will evaluate performance, biocompatibility and safety of a new chronically implantable can and programmable stimulator with high channel feedthrough and assembly for the use in a high channel cochlear and auditory nerve implant that uses the high-density Utah Slant Electrode Array (HD-USEA). The HD-USEA is used as penetrating auditory nerve electrode in a new type of intracranial auditory prosthesis that targets the auditory nerve en route to the brainstem in order to substantially improve hearing performance over the current standard of care, the cochlear implant (CI) (NIH 1UG3NS107688-01). Clinical feasibility and value in human subjects will be demonstrated in a new high channel auditory prosthesis being developed for use in human subjects under an existing UG3/UH3 grant. The current approach is however limited in the ability to use the potentially far higher electrode channel count and subsequent tonal range and resolution due to the limited channel count (12) of the conventional (MED-EL Synchrony) CI stimulator. While this approach is a strength of the UG3/UH3 project that combines existing clinically proven products into one new system as the fastest and lowest risk path towards first in human demonstration, it falls short in using the unique capabilities of the HD- USEA architecture or other higher channel CI electrodes.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2022	BLACKROCK MICROSYSTEMS, INC	630 S KOMAS DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Research Related to Deafness and Communication Disorders	000	3	10/24/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	BLACKROCK MICROSYSTEMS, INC	630 S KOMAS DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Research Related to Deafness and Communication Disorders	001	2	12/5/2022	EXTENSION WITH OR WITHOUT FUNDS	$69,385
2023	2020	BLACKROCK MICROSYSTEMS, INC	630 S KOMAS DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Research Related to Deafness and Communication Disorders	000	1	12/5/2022	NEW	-$69,385
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $728,152 )
2022	2022	BLACKROCK MICROSYSTEMS, INC	630 S KOMAS DR	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Research Related to Deafness and Communication Disorders	000	3	8/22/2022	NON-COMPETING CONTINUATION	$728,152
														Subtotal = $728,152

Issue Date FY: 2021 ( Subtotal = $748,565 )
2021	2021	BLACKROCK MICROSYSTEMS, LLC	630 S KOMAS DR STE 200	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Research Related to Deafness and Communication Disorders	000	2	8/17/2021	EXTENSION WITH OR WITHOUT FUNDS	$748,565
														Subtotal = $748,565

Issue Date FY: 2020 ( Subtotal = $221,177 )
2020	2020	BLACKROCK MICROSYSTEMS, LLC	630 S KOMAS DR STE 200	SALT LAKE CITY	UT	84108	SALT LAKE	USA	Research Related to Deafness and Communication Disorders	000	1	5/5/2020	NEW	$221,177
														Subtotal = $221,177

Grand Total All Awards = $1,697,894

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Development of an AMF Orion/Blackrock HD-USEA based 60/128 channel implantable wireless simulator system for human auditory nerve implants

Award Number: R44DC018757

ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/01/2020

PERIOD OF PERFORMANCE END DATE: 07/31/2024

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