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The purpose of this study is to evaluate the safety and effectiveness of cochlear implantation in adults 65 years of age and older.
The study will be conducted as a single-subject, repeated measures, multi center study at 3 sites. Fifteen subjects will be enrolled in this study. Three centers in the United States and Canada will recruit subjects into this study. Study subjects will be followed for 12 months post-implantation of the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study Procedure | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MED-EL Cochlear Implant System | Device | Cochlear implant and audio processor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the Cochlear Implant System will be assessed through speech perception testing in noise completed through one year (12 months) post implantation. | The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best aided score will be compared to the 6-month and 12-month CI score for AzBio sentences in noise (range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points. | One year (12 months) post implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the Cochlear Implant System will be summarized through speech perception testing in noise completed through one year (12 months) post implantation. | Speech in noise in two spatial conditions will demonstrate similar performance from the pre-operative, best-aided score to the CI score at 6- and 12-months post activation. AzBio sentence in noise score will be summarized for two conditions: speech and noise presented from the front as well as speech presented to the front and noise presented to the CI ear. (Range of score 0-100, higher score is better) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States | ||
| University of North Carolina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28188428 | Background | Arndt S, Laszig R, Aschendorff A, Hassepass F, Beck R, Wesarg T. Cochlear implant treatment of patients with single-sided deafness or asymmetric hearing loss. HNO. 2017 Aug;65(Suppl 2):98-108. doi: 10.1007/s00106-016-0297-5. | |
| 29732951 | Background | Buss E, Dillon MT, Rooth MA, King ER, Deres EJ, Buchman CA, Pillsbury HC, Brown KD. Effects of Cochlear Implantation on Binaural Hearing in Adults With Unilateral Hearing Loss. Trends Hear. 2018 Jan-Dec;22:2331216518771173. doi: 10.1177/2331216518771173. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 29, 2026 | Jun 24, 2026 | 6 |
| ID | Term |
|---|---|
| D046088 | Hearing Loss, Unilateral |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| One year (12 months) post implantation |
| Performance of the Cochlear Implant System will be assessed through speech perception testing in quiet completed through one year (12 months ) post implantation. | Speech perception in quiet will be summarized for the CI ear as well as the contralateral ear at the pre-operative, 6-month, and 12-month intervals. The CI ear is expected to demonstrate improvement (greater than or equal to 10 percentage point change), while the contralateral ear is expected to demonstrate no change. (Range of score 0-100, higher score is better) | One year (12 months) post implantation |
| Subjective benefit of the Cochlear Implant System will be assessed through one year (12 months) post implantation. | Subjective data will be collected via the Speech, Spatial, and Qualities of Hearing Scale (SSQ). Responses will be summarized from the pre-operative, 6-month, and 12-month intervals. (Range of score 0-10, lower score is better) | One year (12 months) post implantation |
| Safety will be evaluated for all study subjects through one year (12 months) post implantation. | Safety will be assessed by collecting and reporting device-related adverse events occurring throughout the study. This will be summarized and reported as the number and proportion of subjects experiencing an adverse device event. | One year (12 months) post implantation |
| Chapel Hill |
| North Carolina |
| 27599 |
| United States |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| 27513880 | Background | Mertens G, De Bodt M, Van de Heyning P. Evaluation of Long-Term Cochlear Implant Use in Subjects With Acquired Unilateral Profound Hearing Loss: Focus on Binaural Auditory Outcomes. Ear Hear. 2017 Jan/Feb;38(1):117-125. doi: 10.1097/AUD.0000000000000359. |
| 12544032 | Background | Niparko JK, Cox KM, Lustig LR. Comparison of the bone anchored hearing aid implantable hearing device with contralateral routing of offside signal amplification in the rehabilitation of unilateral deafness. Otol Neurotol. 2003 Jan;24(1):73-8. doi: 10.1097/00129492-200301000-00015. |
| 18834065 | Background | Van de Heyning P, Vermeire K, Diebl M, Nopp P, Anderson I, De Ridder D. Incapacitating unilateral tinnitus in single-sided deafness treated by cochlear implantation. Ann Otol Rhinol Laryngol. 2008 Sep;117(9):645-52. doi: 10.1177/000348940811700903. |
| 19005250 | Background | Vermeire K, Van de Heyning P. Binaural hearing after cochlear implantation in subjects with unilateral sensorineural deafness and tinnitus. Audiol Neurootol. 2009;14(3):163-71. doi: 10.1159/000171478. Epub 2008 Nov 13. |
| D012678 |
| Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |