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Trial record 3 of 550 for:    "Deafness"

Cochlear Implants for Adults With Single-sided Deafness (SSD)

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ClinicalTrials.gov Identifier: NCT02259192
Recruitment Status : Active, not recruiting
First Posted : October 8, 2014
Last Update Posted : April 20, 2017
Sponsor:
Collaborators:
Med-El Corporation
House Clinic, Inc.
University of California, Los Angeles
Information provided by (Responsible Party):
Robert Shannon, University of Southern California

Brief Summary:
The purpose of this investigation is to determine the safety and preliminary efficacy of implanting a cochlear implant (CI) in the profoundly deaf ear of an adult with one normal hearing (NH) ear (termed "single-sided deaf" person, or SSD). The potential subjects will have been deafened post-lingually, thus, at one point the now deafened ear did conduct sound from the periphery. The MED-EL CI system will be implanted in ten (10) SSD patients.The long-term goal of this research program is to determine whether the CI, in combination with the NH ear, may provide improved localization ability and better speech understanding in noise, relative to performance before cochlear implantation (i.e., with the NH ear alone). A secondary long-term goal is to determine whether CI stimulation may reduce tinnitus severity, compared to tinnitus experienced prior to cochlear implantation or when the CI is turned off, after implantation.

Condition or disease Intervention/treatment Phase
Single-sided Deafness Device: MED-EL Maestro Cochlear Implant Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Cochlear Implantation for Single-Sided Deafness
Study Start Date : September 2014
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open-label
Cochlear Implant
Device: MED-EL Maestro Cochlear Implant
cochlear implant




Primary Outcome Measures :
  1. Pure-tone threshold average (dB) [ Time Frame: 6 months post-activation ]
    Change in 3-frequency pure-tone threshold average (dB) in the normal hearing ear.

  2. Hearing in Noise Test (signal-to-noise ratio) [ Time Frame: 6 months post-activation ]
    Change in Hearing in Noise Test signal-to-noise ratio in the normal hearing ear.


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 1-month post-implantation ]
    Number of unexpected serious adverse events across all 10 subjects.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is an adult (18 years of age or older)
  • English as the primary language
  • Able to undergo general anesthesia, as determined by physical examination and written report from the physician
  • Receives pneumovax vaccine within 2 weeks of surgery and provides documentation to the principal investigator
  • Profoundly/severely deaf in one ear ("implant ear"), as defined by:

    • 3-frequency pure-tone average≥70 dB Hearing Loss
    • Bone conduction thresholds consistent with air conduction thresholds (i.e., no conductive component to the hearing loss)
    • HINT sentence recognition score ≤40% correct, 60 dBA presentation level
    • Post-lingual onset of hearing loss, i.e., after age 6 years of age
    • Hearing loss occurred <10 years prior, as obtained by history
  • Normal hearing in one ear ("non-implant ear"), as defined by:

    • 3-frequency PTA ≤25 dB HL
    • No tested frequency air conduction threshold >35 dB HL
    • Bone conduction thresholds consistent with air conduction thresholds
    • Word recognition score ≥80% correct, 60 dBA presentation level
    • HINT sentence recognition score ≥ 80%, 60 dBA presentation level
  • Provides informed consent
  • Willing and able to follow the study protocol

Exclusion Criteria:

  • Retrocochlear pathology resulting from Neurofibromatosis 2, or other types of cranial nerve/brainstem tumors
  • Co-existing medical conditions that require radiotherapy of the brainstem and/or auditory cortex
  • Any medical contraindication precluding safe administration of general anesthesia, e.g.,

    • Cardiopulmonary disease
    • Renal disease
  • Otologic conditions which contraindicate surgery

    • Active middle ear infection
    • Tympanic membrane perforation
  • Anatomic abnormalities detected on CT preventing appropriate placement of the stimulator housing in the bone of the skull or placement of the electrode array in the cochlea (e.g., ossification)
  • Psychological conditions contraindicating surgery
  • Skin or scalp conditions that may preclude attachment of the coil or that may interfere with the use of the coil
  • Chronic pain in or around the head
  • Current or previous use of an active hearing implant (e.g., bone-anchored hearing aids, cochlear implant, etc.)
  • Developmental delays or organic brain dysfunction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02259192


Locations
United States, California
Keck School of Medicine of USC
Los Angeles, California, United States, 90007
House Clinic
Los Angeles, California, United States, 90057
Sponsors and Collaborators
Robert Shannon
Med-El Corporation
House Clinic, Inc.
University of California, Los Angeles
Investigators
Principal Investigator: Robert Shannon, PhD Keck School of Medicine of USC

Responsible Party: Robert Shannon, Professor of Research, Otolaryngology - Head and Neck Surgery, University of Southern California
ClinicalTrials.gov Identifier: NCT02259192     History of Changes
Other Study ID Numbers: CI for SSD adults
First Posted: October 8, 2014    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017

Keywords provided by Robert Shannon, University of Southern California:
deaf adult
single-sided
cochlear implant

Additional relevant MeSH terms:
Deafness
Hearing Loss
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms