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

NCT05641155 | Completed FDA Device

• 1 other identifier: AI5781
• Study Type: interventional
• Target: 19
• Locations: 2 countries
• Sites: 5

Brief Summary

The purpose of this early feasibility study is to explore several facets of hearing performance that may show improvements for alternative modes of stimulation compared to Monopolar (MP stimulation) in cochlear implant recipients. This study will iteratively evaluate different parameter sets that intend to maximize hearing performance benefits within technical requirements. This study is exploratory in nature and will achieve its objectives through ongoing review and adjustment of device parameters and fitting

Conditions

Hearing Impairment, Sensorineural

Outcome Measures

Primary Outcomes (3)

• Mean difference across maximum map stimulation (C) levels

  Mean difference across maps using alternative modes and sound coding parameters for the highest and average comfortable loudness level (clinical unit) (C-level).

  10 weeks

• Mean difference across Spectral resolution (QSMD)

  Mean difference across maps using alternative modes and sound coding parameters for spectral resolution (% correct) (QSMD - Quick spectral modulation detection)

  10 weeks

• Mean difference across phoneme discrimination (LIT- Language independent test)

  Mean difference across maps using alternative modes and sound coding parameters for phoneme discrimination (% correct) (LIT - Language independent test)

  10 weeks

Study Arms (1)

Adult Cochlear implant

EXPERIMENTAL

Adult cochlear implant recipients receiving different combinations of alternative modes and, sound coding parameters

Device: Focused Multipolar Stimulation (FMS) strategy

Interventions

Focused Multipolar Stimulation (FMS) strategy DEVICE

Adult cochlear implant recipients receiving different combinations of alternative modes and, sound coding parameters.

Adult Cochlear implant

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

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: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); BE (3)