CompletedNot Applicable

Implantation of the Cochlear™ Nucleus® Hybrid S Round Window (S-RW) in Adults

United States6 participantsStarted 2016-02-08

Plain-language summary

Evaluate the Cochlear™ Nucleus® S-Round Window (S-RW) implant in newly implanted adults with broader requirements to be considered an eligible candidate.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Eighteen years of age or older at the time of implantation
✓. Sensorineural hearing loss with the following requirements: a pure tone threshold less (better) than or equal to 60 dB HL at 500 Hz,less than (better) or equal to 80 dB HL at 1500 Hz, and high frequency severe to profound (a threshold average of 2000, 3000, \& 4000 Hz) of \> 60dB HL.
✓. Minimum of 30 days experience with appropriately fit bilateral amplification, fit as described in the Fitting and Use of Hearing Aids section below
✓. Aided monosyllabic word score (e.g., CNC Word Test) (mean of two lists) between 20% and 60%, inclusive (i.e., 20% score 60%), in the ear to be implanted
✓. Aided monosyllabic word score (e.g., CNC Word Test) (mean of two lists) in the contralateral ear equal to, or better than, the ear to be implanted but not more than 80%
✓. Willingness to use bimodal stimulation (i.e., a cochlear implant on one ear and a hearing aid on the contralateral ear) through 12-months post-activation

Exclusion criteria

✕. Individuals aged greater than 75 years
✕. Duration of severe to profound hearing loss (above 2kHz) greater than 20 years
✕. Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
✕. 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 500 to 1000 Hz
✕. Deafness due to lesions of the acoustic nerve or central auditory pathway
✕. Active middle-ear infection or tympanic membrane perforation in the presence of active middle ear disease
✕. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator

What they're measuring

CNC (Consonant-nucleus-consonant) Words

Timeframe: 12 months

Trial details

NCT IDNCT02638883

SponsorCochlear

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-06-12

Results submitted2022-08-10

View on ClinicalTrials.gov More Sensorineural Hearing Loss trials