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

Primary Purpose

Single-sided Deafness

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MED-EL Maestro Cochlear Implant
Sponsored by
Robert Shannon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Single-sided Deafness focused on measuring deaf adult, single-sided, cochlear implant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keck School of Medicine of USC
  • House Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-label

Arm Description

Cochlear Implant

Outcomes

Primary Outcome Measures

Pure-tone threshold average (dB)
Change in 3-frequency pure-tone threshold average (dB) in the normal hearing ear.
Hearing in Noise Test (signal-to-noise ratio)
Change in Hearing in Noise Test signal-to-noise ratio in the normal hearing ear.

Secondary Outcome Measures

Adverse Events
Number of unexpected serious adverse events across all 10 subjects.

Full Information

First Posted
September 26, 2014
Last Updated
April 18, 2017
Sponsor
Robert Shannon
Collaborators
Med-El Corporation, House Clinic, Inc., University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT02259192
Brief Title
Cochlear Implants for Adults With Single-sided Deafness
Acronym
SSD
Official Title
Cochlear Implantation for Single-Sided Deafness
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Robert Shannon
Collaborators
Med-El Corporation, House Clinic, Inc., University of California, Los Angeles

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single-sided Deafness
Keywords
deaf adult, single-sided, cochlear implant

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-label
Arm Type
Experimental
Arm Description
Cochlear Implant
Intervention Type
Device
Intervention Name(s)
MED-EL Maestro Cochlear Implant
Intervention Description
cochlear implant
Primary Outcome Measure Information:
Title
Pure-tone threshold average (dB)
Description
Change in 3-frequency pure-tone threshold average (dB) in the normal hearing ear.
Time Frame
6 months post-activation
Title
Hearing in Noise Test (signal-to-noise ratio)
Description
Change in Hearing in Noise Test signal-to-noise ratio in the normal hearing ear.
Time Frame
6 months post-activation
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Number of unexpected serious adverse events across all 10 subjects.
Time Frame
1-month post-implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Shannon, PhD
Organizational Affiliation
Keck School of Medicine of USC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keck School of Medicine of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90007
Country
United States
Facility Name
House Clinic
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States

12. IPD Sharing Statement

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Cochlear Implants for Adults With Single-sided Deafness

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