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

Primary Purpose

Single Sided Deafness

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Cochlear Nucleus Cochlear Implant System

About this trial

This is an interventional treatment trial for Single Sided Deafness focused on measuring Single sided deafness, Unilateral deafness, Unilateral hearing loss, Cochlear implantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ability to provide informed consent.
Eighteen years-of-age or older at the time of implantation.
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%.
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.
English spoken as a primary language.

Exclusion Criteria:

Alleviation of tinnitus as the stated primary or sole motivation for seeking implantation by the subject and/or investigator.
Actively using an implantable device in the poorer ear.
Onset of severe to profound hearing loss < 6 years-of-age.
Evidence of active middle-ear pathology based on otologic examination and/or immittance testing.
Medical or psychological conditions that contraindicate undergoing surgery.
Ossification or any other cochlear anomaly at the implant ear that might prevent complete insertion of the electrode array.
Hearing loss of neural or central origin, including auditory neuropathy.
Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations inherent to the surgical procedure and prosthetic device.
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.

Sites / Locations

New York University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cochlear Implantation

Arm Description

Cochlear Nucleus Cochlear Implant System

Outcomes

Primary Outcome Measures

Number of Subjects With Adverse Events

Device and procedure-related anticipated and unanticipated aderse events.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01670006

First Posted

August 17, 2012

Last Updated

August 31, 2022

Sponsor

Cochlear

1. Study Identification

Unique Protocol Identification Number

NCT01670006

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cochlear

4. Oversight

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Single Sided Deafness

Keywords

Single sided deafness, Unilateral deafness, Unilateral hearing loss, Cochlear implantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cochlear Implantation

Arm Type

Experimental

Arm Description

Cochlear Nucleus Cochlear Implant System

Intervention Type

Device

Intervention Name(s)

Cochlear Nucleus Cochlear Implant System

Primary Outcome Measure Information:

Title

Number of Subjects With Adverse Events

Description

Device and procedure-related anticipated and unanticipated aderse events.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Hearing in Noise Test (HINT)Score

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ability to provide informed consent. Eighteen years-of-age or older at the time of implantation. Presence of single-sided deafness as follows: 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%. 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%. 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. English spoken as a primary language. Exclusion Criteria: Alleviation of tinnitus as the stated primary or sole motivation for seeking implantation by the subject and/or investigator. Actively using an implantable device in the poorer ear. Onset of severe to profound hearing loss < 6 years-of-age. Evidence of active middle-ear pathology based on otologic examination and/or immittance testing. Medical or psychological conditions that contraindicate undergoing surgery. Ossification or any other cochlear anomaly at the implant ear that might prevent complete insertion of the electrode array. Hearing loss of neural or central origin, including auditory neuropathy. Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations inherent to the surgical procedure and prosthetic device. 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.

Facility Information:

Facility Name

New York University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

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

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