Hearing Loss, Hearing Loss, Cochlear, Hearing Loss in Left Ear, Hearing Loss in Right Ear, Hearing Loss, Sensorineural, Hearing Loss, Sudden, Hearing Loss, Unilateral, Labyrinthitis
Conditions
Keywords
cochlear implantation
Brief summary
This observational study evaluates the effects of cochlear implantation in patients with deafness in one ear.
Detailed description
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.
Interventions
DEVICECochlear implantation
Patients who receive cochlear implant for single-sided deafness
Sponsors
Johns Hopkins University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* For individuals ages 18 years-old and above, limited benefit from unilateral amplification is defined by test scores of 5% correct or less on monosyllabic consonant-nucleus-consonant (CNC) words in quiet when tested in the ear to be implanted alone. * Before implantation with a cochlear implant, individuals with SSD or AHL must have at least 1-month experience wearing a Contra Lateral Routing of Signal (CROS) hearing aid or other relevant device and not show any subjective benefit. * Medical and surgical clearance for cochlear implantation.
Exclusion criteria
* Not meeting FDA candidacy criteria for cochlear implantation in SSD * Inability to perform audiologic tasks (e.g. non-English speaking) * Medical or surgical contraindication to general anesthesia or cochlear implant surgery * Does not wish to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Speech recognition in noise | Baseline and up to 1 year post-implantation | Change in Speech recognition in noise will be assessed using the percent correct on AzBio with multitalker babble at 8dB signal-to-noise ratio. |
| Change in Speech recognition in quiet | Baseline and up to 1 year post-implantation | Change in Speech recognition in quiet will be assessed using the percent correct on Consonant-Noun-Consonant words and phonemes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hearing aid benefit as assessed by the Abbreviated Profile of Hearing Aid Benefit | Baseline and up to 1 year post-implantation | Score on Abbreviated Profile of Hearing Aid Benefit. Range: 0-100. Higher score signifies more frequent problems with hearing. |
| Change in Health utility as assessed by the Health Utility Index | Baseline and up to 1 year post-implantation | Score on Health Utility Index. Range: 0-1.0. Lower score signifies lower health utility. |
| Change in Spatial hearing as assessed by the Spatial Hearing Questionnaire | Baseline and up to 1 year post-implantation | Score on Spatial Hearing Questionnaire. Range: 0-100. Higher score signifies less handicap related to sound localization. |
| Change in Tinnitus handicap as assessed by the Tinnitus Handicap Inventory | Baseline and up to 1 year post-implantation | Score on Tinnitus Handicap Inventory. Range: 0-100. Higher score signifies more handicap due to tinnitus. |
Countries
United States
Outcome results
None listed