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

NCT ID: NCT05641155

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-02

Study Completion Date

2025-12-08

Brief Summary

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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

Detailed Description

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Alternative modes of stimulation will be investigated that may improve spectral resolution through reduced cochlear spread of excitation and in turn provide enhanced speech perception and real-world clinical benefits over MP stimulation. The purpose of this study is to balance the clinical improvements of alternative modes of stimulation with technical and usability requirements for power usage. By iteratively evaluating different sets of stimulation and sound coding parameters, this study will determine device settings and fitting techniques. Measures of speech recognition, listening effort, neural responses, electrode placement, battery life, and usability acceptance will be obtained to evaluate clinical benefits

Conditions

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Hearing Impairment, Sensorineural

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adult Cochlear implant

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

Group Type EXPERIMENTAL

Focused Multipolar Stimulation (FMS) strategy

Intervention Type DEVICE

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

Interventions

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Focused Multipolar Stimulation (FMS) strategy

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1\) 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:

1. 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
2. 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:

1. PTA (500, 1000, 2000, and 4000 Hz) ≥ 70 dB HL for average of 3 out of 4 frequencies
2. Unaided phoneme score ≤ 50% on CVC in quiet at 70 dB SPL in free field
3. ABR peak ≥ 75 dB nHL

2\) 18 years of age or older.

3\) Fluent in the language used for speech testing.

4\) Willing to comply with all investigational requirements.

5\) Willing and able to provide written informed consent

\-

Exclusion Criteria

1. Previous or existing cochlear-implant recipient.
2. Severe or greater sensorineural hearing loss in the ear to be implanted prior to five years of age.
3. Duration of severe to profound hearing loss \> 20 years in the ear to be implanted.
4. Ossification or other cochlear anomaly that might prevent complete insertion of the electrode array.
5. Diagnosis of auditory neuropathy.
6. Deafness due to lesions of the acoustic nerve or central auditory pathway.
7. Pregnant at the time of surgery.
8. Additional handicaps that would prevent or restrict participation in the audiological evaluations.
9. 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.
10. Unable or unwilling to comply with the requirements of the clinical investigation as determined by the Investigator.
11. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
12. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
13. Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cochlear

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rocky Mountain Ear Center

Englewood, Colorado, United States

Site Status

Denver Research and Technology Lab

Lone Tree, Colorado, United States

Site Status

Universitair Ziekenhuis Leuven

Leuven, Leuven, Belgium

Site Status

Cochlear Technology Centre Belgium

Mechelen, Mechelen, Belgium

Site Status

ENT Department, Sint-Augutinus Antwerp

Wilrijk, Wilrijk, Belgium

Site Status

Countries

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United States Belgium

Other Identifiers

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AI5781

Identifier Type: -

Identifier Source: org_study_id