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

NCT ID: NCT01670006

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2016-02-29

Brief Summary

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.

Conditions

Single Sided Deafness

Study Design

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

Study Groups

Cochlear Implantation

Cochlear Nucleus Cochlear Implant System

Group Type: EXPERIMENTAL

Cochlear Nucleus Cochlear Implant System

Intervention Type: DEVICE

Interventions

Cochlear Nucleus Cochlear Implant System

Intervention Type: DEVICE

Eligibility Criteria

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.

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

Sponsors

Cochlear

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

New York University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

CAM5397

Identifier Type: -

Identifier Source: org_study_id