CompletedNot Applicable

A Study of Objective Fitting for Focused Multipolar Stimulation

Spain15 participantsStarted 2024-02-08

Plain-language summary

The purpose of this exploratory study is to trial various objective and behavioural fitting methods for potential use with Focused Multipolar Stimulation programming.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Moderately severe to profound sensorineural hearing loss in both ears. (i.e., \>55 dB HL pure-tone average loss)
✓. Candidate for unilateral cochlear implantation according to locally approved criteria.
✓. Aged 18 years or over.
✓. Fluent speaker in the language used to assess speech perception performance.
✓. Willing and able to provide written informed consent.

Exclusion criteria

✕. 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 families; immediate family is defined as a spouse, parent, child, or sibling.
✕. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
✕. Pregnant at the time of surgery.
✕. Prisoners, or anyone in custody.
✕. Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device.
✕. Previous or existing cochlear-implant recipient.
✕. Evidence of severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age.

What they're measuring

Speech reception threshold (SRT) in noise as a signal-to-noise ratio for 50% correct score.

Timeframe: 6 months

Trial details

NCT IDNCT05763342

SponsorCochlear

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-20

View on ClinicalTrials.gov More Hearing Loss, Bilateral trials