Cochlear Implants for Adults With Single-sided Deafness

NCT ID: NCT02259192

Last Updated: 2017-04-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-09-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Open-label

Cochlear Implant

Group Type: EXPERIMENTAL

MED-EL Maestro Cochlear Implant

Intervention Type: DEVICE

cochlear implant

Interventions

MED-EL Maestro Cochlear Implant

cochlear implant

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Med-El Corporation

INDUSTRY

Sponsor Role: collaborator

House Clinic, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: collaborator

Robert Shannon

OTHER

Sponsor Role: lead

Responsible Party

Robert Shannon

Professor of Research, Otolaryngology - Head and Neck Surgery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Robert Shannon, PhD

Role: PRINCIPAL_INVESTIGATOR

Keck School of Medicine of USC

Locations

Keck School of Medicine of USC

Los Angeles, California, United States

House Clinic

Los Angeles, California, United States

Countries

United States

Other Identifiers

CI for SSD adults

Identifier Type: -

Identifier Source: org_study_id