Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness



Status:Recruiting
Conditions:Other Indications, Other Indications
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:8/23/2018
Start Date:April 2014
End Date:June 2021
Contact:Silke Thode, Ph.D.
Email:clinicalresearch@advancedbionics.com

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The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing
sensitivity can be preserved in newly implanted adults with partial deafness (considerable
low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural
hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™
Mid-Scala electrode to support the development of electro-acoustic stimulation technology
(EAS).


Inclusion criteria: Newly Implanted Group:

- Ability to provide informed consent

- No previous cochlear implant experience in either ear

- 18 years of age or older

- Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone
average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural
hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000,
4,000, and 8,000 Hz) in the ear to be implanted

- Aided CNC word recognition score up to 50% in ear to be implanted

- Up to a moderate sensorineural hearing loss in the low-to-mid frequencies (pure tone
average ≤65 dB for 125, 250, 500, and 1000 Hz) and a severe-to-profound sensorineural
hearing loss in the high frequencies (pure tone average ≥ 70 dB HL for 2,000, 3000,
4,000, and 8,000 Hz) in the contralateral (non-implanted) ear

- Aided CNC word recognition score up to 80% in the contralateral ear

- English language proficiency

- Willingness to use an ear-level sound processor postoperatively for the duration of
the study trial

- Willingness to participate in all scheduled procedures outlined in the protocol

Exclusion Criteria: Newly Implanted Group:

- Preoperative audiometric conductive overlay of 15 dB or greater at two frequencies or
more in range of 500-1000 Hz in the ear to be implanted

- Congenital hearing loss (for purpose of this study, onset prior to age 2 years*).
*Based on critical period for speech and language development

- Duration greater than 30 years of severe-to-profound high-frequency hearing loss

- Cochlear malformation or obstruction that would preclude full insertion of electrode
array in the ear to be implanted

- Medical or psychological conditions that contraindicate surgery or impact the ability
to manage an implanted device or the study related procedures as determined by the
investigator

- Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of
auditory neuropathy/dys-synchrony in either the ear to be implanted or the
contralateral ear

- Active middle-ear disease/infection in the ear to be implanted

- Unrealistic expectations regarding potential benefits, risks and limitations inherent
to implant surgical procedures as determined by the investigator

- Unwillingness or inability of subject to comply with all investigational requirements
as determined by the investigator

EAS Fitting Inclusion Criteria: Newly Implanted and Existing Implanted Groups

- Ability to provide informed consent

- 18 years of age or older, unilaterally implanted with HiRes90K™ Advantage cochlear
implant with HiFocus™ Mid-Scala electrode and fit with an ear-level sound processor
(i.e. Naída family device)

- Postoperative unaided low frequency audiometric hearing thresholds in the treated ear
up to 80 dB HL for at least one frequency from 125 - 1000 Hz

- English Language Proficiency

- Willingness to participate in all scheduled procedures outlined in the study protocol

EAS Fitting Exclusion Criteria: Newly Implanted and Existing Implanted Groups

- Unilaterally implanted with HiRes 90K™ Advantage cochlear implant with HiFocus™ Helix®
and HiFocus™ 1j electrode

- Exclusive use of a body worn external sound processor

- Deafness due to central auditory lesion or cochlear nerve deficiency, diagnosis of
auditory neuropathy/dys-synchrony in either the implanted or the contralateral ear

- Postoperative unaided low frequency audiometric hearing thresholds in the treated ear
exceeding 80 dB HL at each frequency from 125 - 1000 Hz Unwillingness or inability of
subject to comply with all investigational requirements as determined by the
investigator
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Tampa, Florida 33606
Principal Investigator: Loren Bartels, MD
Phone: 813-844-4900
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740 South Limestone Street
Lexington, Kentucky 40536
Phone: 859-218-2167
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Austin, Texas 78705
Principal Investigator: James Kemper, MD
Phone: 512-836-8786
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Columbia, Missouri 65211
(573) 882-2121
Phone: 573-882-2549
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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Nashville, Tennessee 37232
Principal Investigator: David Haynes, MD
Phone: 615-936-2491
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: John T Roland, MD
Phone: 212-263-7567
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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Oklahoma City, Oklahoma 73104
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Principal Investigator: Colin W. Driscoll, MD
Phone: 507-284-1231
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Saint Louis, Missouri 63110
Principal Investigator: Richard A. Chole, MD, PhD
Phone: 314-362-7245
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Saint Louis, Missouri 64111
Principal Investigator: Robert D. Cullen, MD
Phone: 816-932-1671
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Washington, District of Columbia 20057
Principal Investigator: Michael Hoa, MD
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