Status:
TERMINATED
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
Lead Sponsor:
Advanced Bionics
Conditions:
Hearing Loss
Partial Deafness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 aco...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 21 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2022
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT02189798
Start Date
October 21 2014
End Date
March 29 2022
Last Update
May 8 2025
Active Locations (11)
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1
Georgetown University School of Medicine
Washington D.C., District of Columbia, United States, 20007
2
Tampa Bay Hearing and Balance Center
Tampa, Florida, United States, 33606
3
University of Kentucky Medical Center
Lexington, Kentucky, United States, 40536
4
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905