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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult Cochlear implant | Experimental | Adult cochlear implant recipients receiving different combinations of alternative modes and, sound coding parameters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Focused Multipolar Stimulation (FMS) strategy | Device | Adult cochlear implant recipients receiving different combinations of alternative modes and, sound coding parameters. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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) 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:
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
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rocky Mountain Ear Center | Englewood | Colorado | 80113 | United States | ||
| Denver Research and Technology Lab |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 8, 2026 | Jul 1, 2026 | 11 | ||
| Jul 1, 2026 |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Lone Tree |
| Colorado |
| 80124 |
| United States |
| Universitair Ziekenhuis Leuven | Leuven | Leuven | 3000 | Belgium |
| Cochlear Technology Centre Belgium | Mechelen | Mechelen | B-2800 | Belgium |
| ENT Department, Sint-Augutinus Antwerp | Wilrijk | Wilrijk | 2610 | Belgium |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |