CompletedNot Applicable

A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.

United States, Belgium18 participantsStarted 2023-06-02

Plain-language summary

The purpose of this early feasibility study is to explore several facets of hearing performance of Focused Multipolar stimulation in adult cochlear implant users.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. Moderate to profound sensorineural hearing loss, defined as a pure-tone average (PTA) (250 - 1000 Hz) ≥ 40 dB HL and a PTA (2000 - 8000 Hz) ≥ 65 dB HL
. Aided word score ≤ 40% ii) Contralateral ear:
. PTA (500, 1000, 2000, and 4000 Hz) ≥ 70 dB HL for average of 3 out of 4 frequencies
. Unaided phoneme score ≤ 50% on CVC in quiet at 70 dB SPL in free field
. ABR peak ≥ 75 dB nHL

Exclusion criteria

. Previous or existing cochlear-implant recipient.
. Severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age.
. Duration of severe to profound hearing loss \> 20 years in the ear to be implanted.
. Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
. Diagnosis of auditory neuropathy.
. Deafness due to lesions of the acoustic nerve or central auditory pathway.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Difference Between the Maximum C-Level for MAP A and MAP B

Timeframe: 10 weeks

Difference in Spectral Resolution (QSMD) Score Between MAP A and MAP B

Timeframe: 10 weeks

Difference in Language Independent Test (LIT) Score Between MAP A and MAP B

Timeframe: 10 weeks

Trial details

NCT IDNCT05641155

SponsorCochlear

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-06

Results submitted2026-06-08

View on ClinicalTrials.gov More Hearing Impairment, Sensorineural trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. Moderate to profound sensorineural hearing loss, defined as a pure-tone average (PTA) (250 - 1000 Hz) ≥ 40 dB HL and a PTA (2000 - 8000 Hz) ≥ 65 dB HL
. Aided word score ≤ 40% ii) Contralateral ear:
. PTA (500, 1000, 2000, and 4000 Hz) ≥ 70 dB HL for average of 3 out of 4 frequencies
. Unaided phoneme score ≤ 50% on CVC in quiet at 70 dB SPL in free field
. ABR peak ≥ 75 dB nHL

Exclusion criteria

. Previous or existing cochlear-implant recipient.
. Severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age.
. Duration of severe to profound hearing loss \> 20 years in the ear to be implanted.
. Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
. Diagnosis of auditory neuropathy.
. Deafness due to lesions of the acoustic nerve or central auditory pathway.