A Feasibility Study Evaluating the Performance of Focused Multipolar Stimulation and Sound Coding in Adults.
Completed · Not applicable
Conditions studied: Hearing Impairment, Sensorineural
In brief
The purpose of this early feasibility study is to explore several facets of hearing performance of Focused Multipolar stimulation in adult cochlear implant users.
Key facts
- Study ID
- NCT05641155
- Run by
- Cochlear
- People needed
- 18
- Starts
- 2023-06-02
- Expected to finish
- 2025-12-08
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Candidate for unilateral cochlear implantation according to bilateral sensorineural hearing loss criteria, who has decided to proceed with implantation through routine processes.
- a) Bilateral sensorineural hearing loss criteria for clinics in the United States: i) Ear to be implanted:
- 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:
- (1) PTA (500, 1000, 2000, and 4000 Hz) > 30 dB HL (2) Aided word score ≤ 80% b) Bilateral sensorineural hearing loss criteria for clinics in Belgium: i) Both ears:
- 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
- 18 years of age or older.
- Fluent in the language used for speech testing.
- Willing to comply with all investigational requirements.
- Willing and able to provide written informed consent
You may not qualify if…
- 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.
- Pregnant at the time of surgery.
- Additional handicaps that would prevent or restrict participation in the audiological evaluations.
- Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure and prosthetic device.
- 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.
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device
Where it is running
- Rocky Mountain Ear Center — Englewood, Colorado, United States
- Denver Research and Technology Lab — Lone Tree, Colorado, United States
- Universitair Ziekenhuis Leuven — Leuven, Leuven, Belgium
- Cochlear Technology Centre Belgium — Mechelen, Mechelen, Belgium
- ENT Department, Sint-Augutinus Antwerp — Wilrijk, Wilrijk, Belgium
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.