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

NCT05641155 | Completed Results FDA Device

• 1 other identifier: AI5781
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

Hearing Impairment, Sensorineural

Outcome Measures

Primary Outcomes (3)

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

  Difference between the maximum comfortable loudness level C-Level for MAP A and MAP B. This is the maximum current level that provides loud but comfortable sound level for the cochlear implant user.

  10 weeks

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

  Mean difference between MAP A and MAP B for Quick Spectral Modulation Detection (QSMD) test. Higher scores indicate better spectral resolution and generally better ability to distinguish acoustic spectral patterns important for speech understanding. It measures the minimum modulation depth that can be perceived to enable discrimination of a spectrally modulated noise from a flat spectrum noise with the same bandwidth and overall intensity level.

  10 weeks

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

  Mean difference between MAP A and MAP B for the phoneme discrimination test, Language independent test (LIT). The LIT test measures how well a person can hear the difference between speech sounds by asking them to identify which sound is different from the others.

  10 weeks

Study Arms (1)

Cochlear implant user

EXPERIMENTAL

Adult cochlear implant users assessing different Focused Multipolar Stimulation (FMS) programs

Device: Focused Multipolar Stimulation (FMS) strategy

Interventions

Focused Multipolar Stimulation (FMS) strategy DEVICE

Cochlear implant programs (A and B) that utilise FMS with sound coding enhancements

Cochlear implant user

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Cochlear: lead

Study Sites (5)

Rocky Mountain Ear Center

Englewood, Colorado, 80113, United States

Location

Denver Research and Technology Lab

Lone Tree, Colorado, 80124, United States

Location

Universitair Ziekenhuis Leuven

Leuven, Leuven, 3000, Belgium

Location

Cochlear Technology Centre Belgium

Mechelen, Mechelen, B-2800, Belgium

Location

ENT Department, Sint-Augutinus Antwerp

Wilrijk, Wilrijk, 2610, Belgium

Location

MeSH Terms

Conditions

Hearing Loss, Sensorineural

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: cltd-prs-admin@cochlear.com
• Organization: Cochlear Limited

cltd-prs-admin@cochlear.com

+61 2 9428 6555

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: December 7, 2022
• Study Start: June 2, 2023
• Primary Completion: February 6, 2025
• Study Completion: December 8, 2025
• Last Updated: July 29, 2026
• Results First Posted: July 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); BE (3)