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Cochlear Implantation in Cases of Single-Sided Deafness (CI in SSD)

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ClinicalTrials.gov Identifier: NCT02203305
Recruitment Status : Enrolling by invitation
First Posted : July 29, 2014
Last Update Posted : October 20, 2020
Sponsor:
Collaborator:
Med-El Corporation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE July 22, 2014
First Posted Date  ICMJE July 29, 2014
Last Update Posted Date October 20, 2020
Study Start Date  ICMJE October 2014
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
  • demonstrate effectiveness of cochlear implantation on speech perception [ Time Frame: Intervals within the first year of device use ]
    Results on recorded speech perception materials (sentence and word lists)
  • demonstrate the effectiveness of cochlear implantation on localization [ Time Frame: Intervals within the first year of device use ]
    Subjects will identify noise source from an 11-speaker array with the cochlear implant on versus off
  • demonstrate effectiveness of cochlear implantation on subjective benefit [ Time Frame: Intervals within the first year of device use ]
    Subjects will complete subjective questionnaires to indicate perceived benefits of cochlear implantation
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2014)
  • compare speech perception outcomes of cochlear implantation to that of current treatment options [ Time Frame: Intervals within the first year of device use ]
    Results on recorded speech perception materials (sentence and word recognition tasks)
  • compare localization abilities of cochlear implantation to that of current treatment options [ Time Frame: Intervals within the first year of device use ]
    Subjects will identify noise source from an 11-speaker array with the device (cochlear implant / bone-conduction device) on versus off
  • compare subjective benefit of cochlear implantation to that of current treatment options [ Time Frame: Intervals within the first year of device use ]
    Subjects will indicate their perceived benefits of cochlear implantation/other treatment options on subjective questionnaires
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cochlear Implantation in Cases of Single-Sided Deafness
Official Title  ICMJE Cochlear Implantation in Cases of Single-Sided Deafness
Brief Summary The primary goal of this project is to determine whether subjects with Single-Sided Deafness (SSD) experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.
Detailed Description

Single-sided deafness (SSD) can be defined as moderate-to-profound sensorineural hearing loss with limited speech perception benefit in one ear and normal hearing in the contralateral ear. Though one ear is within the normal hearing limits, SSD may result in reduced speech perception in noise, variable abilities on localization tasks, increased subjective report of hearing handicap, and reduced quality of life.

This patient population cannot utilize conventional amplification due to the severity of the hearing loss and poor speech discrimination abilities in the affected ear. Current treatment options include: contralateral routing of the signal (CROS) hearing aids, and bone-conduction devices. A CROS hearing aid is a two-part system that includes a microphone/transmitter on the affected ear and a receiver on the normal hearing ear. The microphone/transmitter sends the acoustic signal from the affected ear to the receiver, which is presented to the normal hearing ear. Bone-conduction devices utilize a percutaneous, implanted titanium abutment to send the acoustic signal from the affected side to the normal hearing ear via vibrations. The goal of both of these technologies is to send the signal from the affected side to the normal hearing side, thereby leaving the patient in a unilateral listening condition.

Though CROS hearing aids and bone-conduction devices provide the patient with auditory information from both sides to the better hearing ear, the ability to use binaural cues for speech perception in noise is variable.

It is of interest whether cochlear implantation of the affected ear would benefit the SSD population. A cochlear implant is a two-part system, including the internal electrode array and external speech processor. The internal electrode array is surgically implanted into the affected cochlea. The external speech processor receives sounds and transmits this signal to the internal portion. The electrode array presents the acoustic signal via electrical pulses within the cochlea, which is interpreted by the brain as sound.

Presumably, cochlear implantation may provide the SSD population improvements in speech perception in the affected ear, which cannot benefit from appropriately fit hearing aids. Cochlear implantation may provide a benefit over current treatment options in the SSD population, as it stimulates the auditory pathway on the affected side, thus allowing for ipsilateral representation of acoustic signals arriving to each ear independently.

The primary goal of this project is to determine whether subjects with SSD experience an improvement in speech perception, localization, and quality of life with a cochlear implant as compared to an unaided listening condition. Secondary aims include: 1) a comparison of speech perception, localization, and quality of life outcomes in the study population to a SSD control group with long-term listening experience with a current treatment option (i.e. bone-conduction device), and 2) a within-subject comparison of speech perception and localization abilities with cochlear implantation versus the bone-conduction test device.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Unilateral Moderate to Profound Hearing Loss
  • Asymmetric Hearing Loss
  • Single-Sided Deafness (SSD)
Intervention  ICMJE
  • Device: Cochlear Implant
    cochlear implantation used a treatment for single-sided deafness and/or asymmetric hearing loss
    Other Names:
    • MED-EL CONCERT cochlear implant system
    • MED-EL SYNCHRONY cochlear implant system
  • Other: Control Group
    Subjects in the control group will have had listening experience with a bone-conduction device, which is an approved treatment for SSD.
    Other Name: bone-conduction device
Study Arms  ICMJE
  • Experimental: Cochlear Implant
    Cochlear implantation of the affected ear
    Intervention: Device: Cochlear Implant
  • Control Group
    A control group without the study intervention (cochlear implantation) will complete the test battery.
    Intervention: Other: Control Group
  • Experimental: Cochlear Implant: Asymmetric hearing loss
    Cochlear implantation of the poorer hearing ear
    Intervention: Device: Cochlear Implant
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: February 4, 2016)
50
Original Estimated Enrollment  ICMJE
 (submitted: July 25, 2014)
30
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria (SSD):

  • Unilateral moderate-to-profound sensorineural hearing loss [Unaided residual hearing thresholds measured from 250-8000 Hertz (Hz) (Pure Tone Average (PTA) ≥70 decibel (dB) Hearing Level (HL) in the ear to be implanted]
  • Normal to mild residual hearing thresholds from 250-8000 Hz in the contralateral ear (≤35 dB HL at each frequency, 250-8000 Hz)
  • Greater than or equal to 18 years of age at implantation
  • Duration of moderate-to-profound sensorineural hearing loss less than or equal to 5 years [Either reported by subject or documented in previous audiograms] [Can be less than or equal to 10 years if the subject consistently utilized hearing technology (such as a bone conduction device or conventional hearing aid) within the past 5 years]
  • Previous experience with a current treatment option for SSD, including a conventional hearing aid, bone-conduction device, or CROS/BICROS (Bilateral Contralateral Routing Of the Signal) technology. [At least one month of listening experience with device] [Dissatisfaction with and/or discontinued use of current treatment option due to: insufficient gain, poor sound quality, and/or lack of perceived benefit]
  • Aided word recognition in the ear to be implanted of 60% or less as measured with Consonant-Nucleus-Consonant (CNC) words (50-word list) [When listening with an appropriately fit hearing aid and masking applied to the contralateral ear] [Aided testing will be conducted in a sound-proof booth with the subject seated 1 meter from the sound source, facing 0° azimuth. Recorded materials will be presented at 60 dB Sound Pressure Level (SPL).] [The hearing aid output will be measured using National Acoustic Laboratory-NonLinear (NAL-NL1) targets.]
  • Realistic expectations
  • Willing to obtain recommended meningitis vaccinations per Center for Disease Control (CDC) recommendations
  • No reported cognitive issues [Pass the Mini Mental State Examination (MMSE) screener]
  • Able and willing to comply with study requirements, including travel to investigational site and study-related activities

Exclusion Criteria (SSD):

  • Non-native English speaker [Speech perception materials are presented in English]
  • Conductive hearing loss in either ear
  • Compromised auditory nerve, including those with a history of vestibular schwannoma
  • Ossification
  • Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
  • History of meningitis, autoimmune disease, or any medical condition that contraindicate middle or inner ear surgery or anesthesia
  • Meniere's disease with intractable vertigo
  • Trauma that precludes inner ear surgery
  • Case of sudden sensorineural hearing loss that has not been first evaluated by a physician
  • Pregnancy [Subjects who are pregnant or become pregnant prior to surgery are excluded due to the potential risk of anesthesia to an unborn child.] [Subjects who become pregnant after surgery may continue to participate in study procedures]
  • Tinnitus as the primary purpose for seeking cochlear implantation
  • Subject obtains a severe or catastrophic score on the Tinnitus Handicap Inventory (Newman, Jacobson & Spitzer, 1996).

Inclusion Criteria (asymmetric hearing loss):

a. Ear to be implanted i. Moderate-to-profound sensorineural hearing loss ii. PTA ≥70 dB HL iii. Aided word recognition of 60% or less as measured with CNC words (50-word list).

b. Contralateral ear i. PTA ≥35 and ≤55 dB HL ii. Aided word recognition of 80% or more as measured with CNC words (50-word list).

iii. Use of conventional amplification c. Greater than or equal to 18 years of age at implantation d. Duration of moderate-to-profound sensorineural hearing loss in the ear to be implanted is less than or equal to 5 years [Either reported by subject or documented in previous audiograms. Can be up to 10 years if the subject consistently utilized hearing technology in the ear to be implanted (such as a bone conduction device or conventional hearing aid) within the past 5 years] e. Previous experience with a current treatment option for asymmetric hearing loss, including a conventional hearing aid, bone-conduction device, or CROS/BiCROS technology. [At least one month of listening experience with device. Dissatisfaction with and/or discontinued use of current treatment option due to: insufficient gain, poor sound quality, and/or lack of perceived benefit.] f. Realistic expectations g. Willing to obtain recommended meningitis vaccinations per CDC recommendations h. No reported cognitive issues [Pass the Mini Mental State Examination (MMSE) screener] i. Able and willing to comply with study requirements, including travel to investigational site and study-related activities

Exclusion Criteria (Asymmetric hearing loss):

  1. Non-English speaker [Speech perception materials are presented in English]
  2. Medical condition considered a contraindication to undergoing cochlear implantation
  3. Conductive hearing loss in either ear
  4. Compromised auditory nerve, including those with a history of vestibular schwannoma
  5. Ossification
  6. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)
  7. History of meningitis, autoimmune disease, or any medical condition that contraindicate middle or inner ear surgery or anesthesia
  8. Meniere's disease with intractable vertigo
  9. Trauma that precludes inner ear surgery
  10. Case of sudden sensorineural hearing loss that has not been first evaluated by a physician
  11. Pregnancy [Subjects who are pregnant or become pregnant prior to surgery are excluded due to the potential risk of anesthesia to an unborn child. Subjects who become pregnant after surgery may continue to participate in study procedures]
  12. Tinnitus as the primary purpose for seeking cochlear implantation
  13. Subject obtains a severe or catastrophic score on the Tinnitus Handicap Inventory (Newman, Jacobson & Spitzer, 1996).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02203305
Other Study ID Numbers  ICMJE 14-1544
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE Med-El Corporation
Investigators  ICMJE
Principal Investigator: Margaret Dillon, AuD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP