Cochlear Implantation for Treatment of Single-sided Deafness

April 23, 2020 updated by: Dr. Daniel Lee
This is a research study to determine whether a cochlear implantation (CI) device can improve hearing in people who are deaf in one ear (known as single-sided deafness).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The goal of this study is to further investigate the role of CI in treating unilateral hearing loss and associated tinnitus. Single-sided deafness (SSD) afflicts approximately 60,000 new patients per year in the United States. The most common causes of these single-sided losses are sudden sensorineural hearing loss, Meniere's disease, trauma, and vestibular schwannoma. Patients with SSD face significant difficulty with communicating in the presence of background noise and in sound localization. Another significant problem for some SSD patients is tinnitus, which can be incapacitating and for which there are no therapies available that are considered to be of sufficient reliability to become a standard of care. Difficulty hearing in background noise and increased tinnitus can lead to significant frustration in social situations and contribute to increased isolation and a decreased quality of life. Treatment options for single sided deafness in the United States include contralateral routing of signals (CROS) hearing aids, bone-anchored hearing aids (BAHA) and use of assistive devices to improve the signal-to-noise in group situations. The first two devices take sound from the affected ear and transmit it to the unaffected ear. The last device consists of having a speaker wear a microphone and routing the signal directly to the patient's ear at a louder listening level. Although these devices can improve speech understanding in some patients, studies have shown that use of these devices does not ameliorate tinnitus or sound localization difficulties. Recent European studies have demonstrated that cochlear implantation (CI) can provide significant improvements in both perceived hearing ability and measured speech comprehension and localization in adult and pediatric patients with unilateral hearing loss. This suggests that CI may be a more effective option for this patient population than the CROS, BAHA or assistive devices.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts Eye and Ear Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older with the ability to provide informed consent
  • English as the primary language
  • Medically and psychologically suitable
  • Willing to receive/have received meningitis vaccinations
  • Able to pay for all care received through the study, either through the subject's insurance company or through self-pay
  • Able to comply with study requirements, including travel to the investigational sites
  • Severe to profound sensorineural hearing loss (≥70 dB HL (decibel hearing level) thresholds between 500 and 4000 Hz) in the worse ear with ≤ 20% Consonant-Nucleus-Consonant (CNC) word scores
  • Duration of single-sided deafness ≥ one year

  • Tinnitus localized to the affected ear, both ears, or in the head localized to the affected ear, both ears, or in the head

    • Expected subjects include those with:
  • Unilateral hearing loss secondary to viral or bacterial infection, such as meningitis or labyrinthitis
  • Ménière's disease
  • Sudden sensorineural hearing loss
  • Vascular disease affecting the inner ear
  • A combination of any number of the above conditions

Exclusion Criteria:

  • Duration of single-sided deafness ≥ ten years
  • Pure tone thresholds ≥ 35 dB HL at 500, 1000, 2000, and 4000 Hz in the better ear
  • Consonant-Nucleus-Consonant (CNC) word scores ≤ 70% in the better ear
  • Chronic otitis media in either ear
  • Inner ear malformation in either ear
  • Autoimmune inner ear disease (fluctuation sensorineural hearing loss in either ear)
  • Evidence of retrocochlear pathology, including vestibular schwannoma
  • Unilateral tinnitus in the unaffected ear
  • Cochlear ossification
  • Demonstrated cognitive and/or developmental challenges
  • Major depression or anxiety; post-traumatic stress disorder; substance abuse
  • Medical or psychological conditions that serve as contraindication to surgery
  • Additional handicaps that would prevent or limit participation in evaluations
  • Unrealistic patient or family expectations regarding the benefits, risks, and limitations inherent to the procedure and the prosthetic device
  • Pregnant women: The investigators will specifically ask all women of childbearing age if there is a possibility they are pregnant or trying to become pregnant at the initial clinic visit; any women who are pregnant or actively trying to become pregnant will be excluded. In cases that are questionable on the day of planned surgery, a pregnancy test will be performed as per current Massachusetts Eye & Ear Infirmary anesthesia pre-operative protocols.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cochlear Implant surgery
All subjects will be part of a single arm involving placement of the Med-El MAESTRO Cochlear Implant with Flex 28 electrode array
Device: Med-el MAESTRO Cochlear Implant with Flex 28 electrode array
Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.
Other Names:
  • CI
  • cochlear implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sound Detection Via Pure-tone Threshold Audiometry (PTA)
Time Frame: 3, 6 and 12 months post-operatively
Sound field thresholds following cochlear implantation via pure-tone threshold audiometry. Measured in dB HL (decibels hearing level) where a lower number means more sensitive hearing and a higher number means less sensitive hearing.
3, 6 and 12 months post-operatively
Speech Perception Following Cochlear Implantation Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
Time Frame: Preop, 1-4 weeks, and 3, 6, and 12 months post-operatively
Ability to recognize words and sentences read by the tester from a set list at a loudness of 65 dB HL. The outcome is measured as a percent score of words recognized. The test takes place in a quiet environment.
Preop, 1-4 weeks, and 3, 6, and 12 months post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective Changes in Tinnitus Following Cochlear Implantation Measured by Tinnitus Handicap Index (THI)
Time Frame: Preop and 12 months post-operatively
Tinnitus severity rated by the Tinnitus Handicap Index (THI). The THI score of 0-16 means "no or slight handicap", 18 to 36 indicates "mild", 38 to 56 indicates "moderate", 58 to 76 indicates "severe", and a score of 78-100 is classified as "catastrophic handicap"
Preop and 12 months post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Daniel Lee

Collaborators

University of Wisconsin, Madison

Investigators

  • Principal Investigator: Daniel J Lee, MD, FACS, MEEI / MGH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2015

Primary Completion (ACTUAL)

February 27, 2019

Study Completion (ACTUAL)

April 25, 2019

Study Registration Dates

First Submitted

August 14, 2015

First Submitted That Met QC Criteria

August 21, 2015

First Posted (ESTIMATE)

August 26, 2015

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2020

Last Update Submitted That Met QC Criteria

April 23, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-054H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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