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

Not Applicable

Active, not recruiting

• Conditions: Hearing Impairment, Sensorineural
• Interventions: Device: Focused Multipolar Stimulation (FMS) strategy

• Registration Number: NCT05641155
• Lead Sponsor: Cochlear

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-12-07
• Study Start: 2023-06-02
• Primary Completion: 2025-02-06
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-25
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adult Cochlear implant	Focused Multipolar Stimulation (FMS) strategy	Adult cochlear implant recipients receiving different combinations of alternative modes and, sound coding parameters

Primary Outcome Measures

Name	Time	Method
Mean difference across maximum map stimulation (C) levels	10 weeks	Mean difference across maps using alternative modes and sound coding parameters for the highest and average comfortable loudness level (clinical unit) (C-level).
Mean difference across Spectral resolution (QSMD)	10 weeks	Mean difference across maps using alternative modes and sound coding parameters for spectral resolution (% correct) (QSMD - Quick spectral modulation detection)
Mean difference across phoneme discrimination (LIT- Language independent test)	10 weeks	Mean difference across maps using alternative modes and sound coding parameters for phoneme discrimination (% correct) (LIT - Language independent test)

Trial Locations

Locations (5)

Rocky Mountain Ear Center; 🇺🇸 Englewood, Colorado, United States

Denver Research and Technology Lab; 🇺🇸 Lone Tree, Colorado, United States

Universitair Ziekenhuis Leuven; 🇧🇪 Leuven, Belgium

Cochlear Technology Centre Belgium; 🇧🇪 Mechelen, Belgium

ENT Department, Sint-Augutinus Antwerp; 🇧🇪 Wilrijk, Belgium