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
We found this trial at
11
sites
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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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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Nashville, TN
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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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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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Tampa, Florida 33606
Principal Investigator: Loren Bartels, MD
Phone: 813-844-4900
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Washington, District of Columbia 20057
Principal Investigator: Michael Hoa, MD
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