Implantation of the Cochlear® Nucleus® System in Adults With Single-Sided Deafness

The objective of this feasibility study is to obtain preliminary safety and efficacy data associated with cochlear implantation in individuals with severe to profound sensorineural hearing loss contralateral to an ear with normal, or near-normal, hearing. The hypothesis is that restoration of hearing in the deafened ear will result in improved speech perception in the treated ear and advantages related to restoration of hearing to both ears.

Study Overview

• Status: Completed
• Conditions: Single Sided Deafness
• Intervention / Treatment: Device: Cochlear Nucleus Cochlear Implant System

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University Medical Center

Participation Criteria

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:

1. Ability to provide informed consent.
2. Eighteen years-of-age or older at the time of implantation.

3. Presence of single-sided deafness as follows:

   1. Poorer ear (ear to be implanted):

      • severe to profound sensorineural hearing loss, defined as pure-tone thresholds 80 dB HL or greater for the frequencies 500, 1000, 2000, 3000, and 4000 Hz.
      • Monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, less than or equal to 10%.

   2. Better ear (contralateral ear):

      • Normal or near-normal hearing, defined as pure-tone thresholds no poorer than 30 dB HL at 250, 500, 1000, 2000, and 3000 Hz and no poorer than 40 dB HL at 4000 Hz.
      • Monosyllabic word understanding, as measured using the CNC Word Test at 60 dBA under earphones, of greater than or equal to 90%.
4. Duration of severe to profound sensorineural hearing loss of at least 6 months (to ensure stability of hearing loss) but no greater than 10 years.
5. English spoken as a primary language.

Exclusion Criteria:

1. Alleviation of tinnitus as the stated primary or sole motivation for seeking implantation by the subject and/or investigator.
2. Actively using an implantable device in the poorer ear.
3. Onset of severe to profound hearing loss < 6 years-of-age.
4. Evidence of active middle-ear pathology based on otologic examination and/or immittance testing.
5. Medical or psychological conditions that contraindicate undergoing surgery.
6. Ossification or any other cochlear anomaly at the implant ear that might prevent complete insertion of the electrode array.
7. Hearing loss of neural or central origin, including auditory neuropathy.
8. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations inherent to the surgical procedure and prosthetic device.
9. Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure, as determined by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cochlear Implantation; Cochlear Nucleus Cochlear Implant System	Device: Cochlear Nucleus Cochlear Implant System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Adverse Events	Device and procedure-related anticipated and unanticipated aderse events.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing in Noise Test (HINT)Score	To access speech perception performance using Hearing in noise test sentences in noise was measured at 12 months post activation. Recorded HINT sentences were presented to participants at 60dBA pre-operatively and 12 months post activation. Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome.	12 months

Collaborators and Investigators

• Sponsor: Cochlear

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: August 17, 2012
• First Submitted That Met QC Criteria: August 17, 2012
• First Posted (Estimate): August 21, 2012

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: August 31, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Cochlear implantation; Single sided deafness; Unilateral deafness; Unilateral hearing loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: CAM5397

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes