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This observational study evaluates the effects of cochlear implantation in patients with deafness in one ear.
Cochlear implant (CI) technology has been widely used for individuals with bilateral sensorineural hearing loss to improve the ability to perceive sound by bypassing the damaged portion of the inner ear. Recently in the U.S., Cochlear implantation has also been approved by the FDA for treatment of single-sided deafness. By restoring binaural hearing, cochlear implantation in unilateral hearing loss may improve hearing in noise and sound localization, however its audiologic outcomes and quality of life impact for patients remain incompletely understood.
This study aims to establish a prospective database to track and quantify the change in general health status, tinnitus severity, spatial hearing ability, and difficulty with communication in noise after unilateral cochlear implantation in patients with SSD undergoing routine medical and audiologic evaluation at the Johns Hopkins Cochlear Implant Center. Study participants will complete survey questionnaires and undergo standard-of-care audiological evaluation before and after cochlear implantation. Data collected in this study will be invaluable in gaining an in-depth understanding of the effects of cochlear implantation in patients with SSD in the context of current FDA guidelines, and lead to better counseling and patient selection for this treatment modality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear implant recipients | Patients with single-sided deafness undergoing cochlear implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear implantation | Device | Patients who receive cochlear implant for single-sided deafness |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Speech recognition in quiet | Change in Speech recognition in quiet will be assessed using the percent correct on Consonant-Noun-Consonant words and phonemes. | Baseline and up to 1 year post-implantation |
| Change in Speech recognition in noise | Change in Speech recognition in noise will be assessed using the percent correct on AzBio with multitalker babble at 8dB signal-to-noise ratio. | Baseline and up to 1 year post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Spatial hearing as assessed by the Spatial Hearing Questionnaire | Score on Spatial Hearing Questionnaire. Range: 0-100. Higher score signifies less handicap related to sound localization. | Baseline and up to 1 year post-implantation |
| Change in Tinnitus handicap as assessed by the Tinnitus Handicap Inventory |
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Inclusion Criteria:
Exclusion Criteria:
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The study population comprises individuals with single-sided deafness or asymmetric hearing loss resulting in poor hearing in one ear.
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Sun, MD | JHU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview | Baltimore | Maryland | 21224 | United States | ||
| Johns Hopkins Outpatient Center |
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Score on Tinnitus Handicap Inventory. Range: 0-100. Higher score signifies more handicap due to tinnitus. |
| Baseline and up to 1 year post-implantation |
| Change in Hearing aid benefit as assessed by the Abbreviated Profile of Hearing Aid Benefit | Score on Abbreviated Profile of Hearing Aid Benefit. Range: 0-100. Higher score signifies more frequent problems with hearing. | Baseline and up to 1 year post-implantation |
| Change in Health utility as assessed by the Health Utility Index | Score on Health Utility Index. Range: 0-1.0. Lower score signifies lower health utility. | Baseline and up to 1 year post-implantation |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| Johns Hopkins Suburban | Bethesda | Maryland | 20814 | United States |
| Johns Hopkins Greenspring Station | Lutherville-Timonium | Maryland | 21093 | United States |
| Johns Hopkins White Marsh | Nottingham | Maryland | 21236 | United States |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D006319 | Hearing Loss, Sensorineural |
| D046088 | Hearing Loss, Unilateral |
| D003639 | Hearing Loss, Sudden |
| D007762 | Labyrinthitis |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007759 | Labyrinth Diseases |
| D010031 | Otitis |
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| ID | Term |
|---|---|
| D019929 | Cochlear Implantation |
| ID | Term |
|---|---|
| D013506 | Otologic Surgical Procedures |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
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