Cochlear Implants for Adults With Single-sided Deafness

NCT02259192 | Unknown

• 1 other identifier: CI for SSD adults
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Single-sided Deafness

Keywords

deaf adult; single-sided; cochlear implant

Outcome Measures

Primary Outcomes (2)

• Pure-tone threshold average (dB)

  Change in 3-frequency pure-tone threshold average (dB) in the normal hearing ear.

  6 months post-activation

• Hearing in Noise Test (signal-to-noise ratio)

  Change in Hearing in Noise Test signal-to-noise ratio in the normal hearing ear.

  6 months post-activation

Secondary Outcomes (1)

• Adverse Events

  1-month post-implantation

Study Arms (1)

Open-label

EXPERIMENTAL

Cochlear Implant

Device: MED-EL Maestro Cochlear Implant

Interventions

MED-EL Maestro Cochlear Implant DEVICE

cochlear implant

Open-label

Eligibility Criteria

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

You may qualify if:

• 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:
• 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:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Robert Shannon: lead
• Med-El Corporation: collaborator
• House Clinic, Inc.: collaborator
• University of California, Los Angeles: collaborator

Study Sites (2)

Keck School of Medicine of USC

Los Angeles, California, 90007, United States

Location

House Clinic

Los Angeles, California, 90057, United States

Location

Study Officials

• Robert Shannon, PhD

  Keck School of Medicine of USC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Research, Otolaryngology - Head and Neck Surgery

Study Record Dates

• First Submitted: September 26, 2014
• First Posted: October 8, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2019
• Study Completion: September 1, 2019
• Last Updated: April 20, 2017

Record last verified: 2017-04

Locations

US (2)