Clinical trial NCT05052944: Single-sided Deafness and Cochlear Implantation
Official title: Single-sided Deafness and Cochlear Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Hearing Loss, Sensorineural
Hearing Loss, Unilateral
Hearing Loss, Sudden
Hearing Loss, Cochlear
Hearing Loss in Left Ear
Hearing Loss in Right Ear
Labyrinthitis
Keywords: cochlear implantation
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises individuals with single-sided deafness or asymmetric hearing loss resulting in poor hearing in one ear.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Speech recognition in quiet
timeFrame: Baseline and up to 1 year post-implantation
measure: Change in Speech recognition in noise
timeFrame: Baseline and up to 1 year post-implantation
Secondary outcomes:
measure: Change in Spatial hearing as assessed by the Spatial Hearing Questionnaire
timeFrame: Baseline and up to 1 year post-implantation
measure: Change in Tinnitus handicap as assessed by the Tinnitus Handicap Inventory
timeFrame: Baseline and up to 1 year post-implantation
measure: Change in Hearing aid benefit as assessed by the Abbreviated Profile of Hearing Aid Benefit
timeFrame: Baseline and up to 1 year post-implantation
measure: Change in Health utility as assessed by the Health Utility Index
timeFrame: Baseline and up to 1 year post-implantation
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center
state: Maryland
city: Bethesda
country: United States
facility: Johns Hopkins Suburban
state: Maryland
city: Lutherville-Timonium
country: United States
facility: Johns Hopkins Greenspring Station
state: Maryland
city: Nottingham
country: United States
facility: Johns Hopkins White Marsh
state: Maryland
Study officials:
affiliation: JHU
name: Daniel Sun, MD
role: PRINCIPAL_INVESTIGATOR
References: