Single-sided Deafness and Cochlear Implantation

NCT05052944 | Completed FDA Device

• 1 other identifier: IRB00230644
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 5

Brief Summary

This observational study evaluates the effects of cochlear implantation in patients with deafness in one ear.

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Change in Spatial hearing as assessed by the Spatial Hearing Questionnaire

  Baseline and up to 1 year post-implantation

• Change in Tinnitus handicap as assessed by the Tinnitus Handicap Inventory

  Baseline and up to 1 year post-implantation

• Change in Hearing aid benefit as assessed by the Abbreviated Profile of Hearing Aid Benefit

  Baseline and up to 1 year post-implantation

• Change in Health utility as assessed by the Health Utility Index

  Baseline and up to 1 year post-implantation

Study Arms (1)

Cochlear implant recipients

Patients with single-sided deafness undergoing cochlear implantation

Device: Cochlear implantation

Interventions

Cochlear implantation DEVICE

Patients who receive cochlear implant for single-sided deafness

Also known as: Med El cochlear implant

Cochlear implant recipients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (5)

Johns Hopkins Bayview

Baltimore, Maryland, 21224, United States

Location

Johns Hopkins Outpatient Center

Baltimore, Maryland, 21287, United States

Location

Johns Hopkins Suburban

Bethesda, Maryland, 20814, United States

Location

Johns Hopkins Greenspring Station

Lutherville-Timonium, Maryland, 21093, United States

Location

Johns Hopkins White Marsh

Nottingham, Maryland, 21236, United States

Location

MeSH Terms

Conditions

Hearing Loss; Hearing Loss, Sensorineural; Hearing Loss, Unilateral; Hearing Loss, Sudden; Labyrinthitis

Interventions

Cochlear Implantation

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Labyrinth Diseases; Otitis

Intervention Hierarchy (Ancestors)

Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation

Study Officials

• Daniel Sun, MD

  JHU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 22, 2021
• Study Start: November 19, 2020
• Primary Completion: July 24, 2023
• Study Completion: November 9, 2023
• Last Updated: November 13, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)