NCT04741048
Withdrawn
N/A
A Pre-market, Open-label Feasibility, Prospective, Single-arm Multicenter Feasibility Investigation of Hearing Performance Using the CI624 in Adults With Low-frequency Residual Hearing.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Sensorineural Hearing Loss
- Sponsor
- Cochlear
- Locations
- 1
- Primary Endpoint
- Characterize hearing performance of the CI624.
- Status
- Withdrawn
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI624 in a group of adults (n=15) with low-frequency residual hearing who meet inclusion criteria.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years-of-age or older at the time of surgery.
- •Low-frequency threshold at 500 Hz ≤ 50 dB HL and high-frequency pure-tone average (PTA), 2000-8000 Hz ≥ 65 dB HL in the ear to be implanted.
- •Pure-tone average (PTA) (0.5k, 1k, 2k Hz) \> 30 dB HL in the contralateral ear.
- •CNC word recognition scores (mean of two lists) ≤ 60% in the ear to be implanted and ≤ 80% in the contralateral ear.
- •English spoken as a primary language.
- •Willing and able to provide written informed consent.
Exclusion Criteria
- •Individuals older than 70 years at the time of surgery.
- •Duration of severe to profound sensorineural hearing loss \> 20 years per self-report.
- •Onset of sensorineural hearing loss, for the purpose of this study, prior to 5 years-of-age.
- •Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array.
- •Conductive overlay of 15 dB or greater at two or more frequencies, in the range of 250 through 1000 Hz in the ear to be implanted.
- •Hearing loss of neural or central origin.
- •Diagnosis of Auditory Neuropathy.
- •Active middle-ear infection.
- •Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator.
- •Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the device and/or procedure, as determined by the Investigator.
Outcomes
Primary Outcomes
Characterize hearing performance of the CI624.
Time Frame: 14 months
Hearing performance of the CI624 will characterized using Constant Nucleus Constant (CNC) word recognition in quiet. Performance is scored as percent correct words.
Study Sites (1)
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