Hearing Implant Performance in Adults With Low-Frequency Residual Hearing

  • STATUS
    Recruiting
  • End date
    Apr 10, 2023
  • participants needed
    15
  • sponsor
    Cochlear
Updated on 10 April 2021

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.

Details
Condition Sensorineural hearing loss, Hearing Loss, Auditory Loss and Deafness, Hearing Impairment, Low-Frequency Residual Hearing, Low-Frequency Residual Hearing
Treatment CI624 Slim 20 Electrode
Clinical Study IdentifierNCT04741048
SponsorCochlear
Last Modified on10 April 2021

Eligibility

Yes No Not Sure

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
Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator
Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator
Investigator site personnel directly affiliated with this study and/or their immediate family (spouse, parent, child, or sibling)
Cochlear employees or employees of a Contract Research Organization (CRO) or contractors engaged by Cochlear for the purposes of this investigation
Currently participating, or has participated in the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device
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