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Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy

Primary Purpose

Hearing Loss

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

cochlear implant

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Eighteen years of age or older at the time of the study.
Preoperative aided CNC word score in quiet of greater than or equal to 10% and less than or equal to ¬¬40% in the ear to be implanted; equal to but no better than 50% in the contralateral ear
Bilateral moderate to profound hearing loss in the low frequencies (up to 1000 Hz) and profound sensorineural hearing loss in the high speech frequencies (3000 Hz and above)
Willingness to use bimodal stimulation (i.e. a cochlear implant on one ear and a hearing aid on the contralateral ear) through at least 6-months postactivation.
English spoken as the primary language.

Exclusion Criteria:

Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age).
Preoperative aided HINT sentence score less than or equal to 50% in the ear to be implanted
Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array.
Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway).
Active middle-ear infection.
Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

cochlear implant

Arm Description

Outcomes

Primary Outcome Measures

CNC Monosyllabic Word Score - Treated Ear

The primary study endpoint was to test whether a statistically significant difference could be obtained between the mean, preoperative Consonant Nucleus Consonant (CNC) monosyllabic word score in the ear to be implanted compared to the postoperative CNC word score in the cochlear implant alone condition at 6 months postimplant activation for candidates who currently perform outside the approved Nucleus® cochlear implant candidacy requirements. CNC Word Test is a validated test of open-set word recognition. The test consists of 10 lists with 50 monosyllabic words in each list. Subject responses are scored for both words and phonemes correct in the correct sequence. Subjects will be tested using a configuration of speech at 0º azimuth in quiet.

Secondary Outcome Measures

Full Information

NCT ID

NCT01337076

First Posted

April 14, 2011

Last Updated

September 23, 2016

Sponsor

Cochlear

1. Study Identification

Unique Protocol Identification Number

NCT01337076

Brief Title

Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy

Official Title

Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cochlear

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The Sponsor values the progression of hearing healthcare practice and acknowledges a need for re-evaluation of indications for determining adult cochlear implant candidacy. This need arises from current research, peer reviewed literature, and technological advancement with concomitant performance outcomes. To address this specifically, the Sponsor proposes to evaluate the safety and efficacy of the Cochlear™ Nucleus® implant system with a revised indication.

Detailed Description

Existing research, as discussed, supports the opinion that current candidacy criteria are set conservatively. The Sponsor, in addition to the support of recent peer reviewed literature illustrating a need for an appropriate criteria and more suitable speech recognition measure, believe it is appropriate at this time to re-evaluate the candidacy requirements associated with adult cochlear implantation. Specifically, this will be accomplished by evaluating the safety and efficacy of the Cochlear™ Nucleus® cochlear implant system under revised cochlear implant indications. The proposed approach would be to evaluate individuals scoring between 10 - 40% inclusively on Consonant Nucleus Consonant (CNC) monosyllabic words who do not meet current approved speech perception criteria with the widely used sentence measure Hearing In Noise Test (HINT) in quiet. No change to current qualifying audiometric criteria (bilateral moderate to profound sensorineural hearing loss in the low frequencies and profound hearing loss in the mid to high speech frequencies) for implant candidacy is proposed.

6. Conditions and Keywords

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

Hearing Loss

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

cochlear implant

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

cochlear implant

Other Intervention Name(s)

implantable hearing device

Intervention Description

Cochlear implant surgery

Primary Outcome Measure Information:

Title

CNC Monosyllabic Word Score - Treated Ear

Description

Time Frame

Six months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Eighteen years of age or older at the time of the study. Preoperative aided CNC word score in quiet of greater than or equal to 10% and less than or equal to ¬¬40% in the ear to be implanted; equal to but no better than 50% in the contralateral ear Bilateral moderate to profound hearing loss in the low frequencies (up to 1000 Hz) and profound sensorineural hearing loss in the high speech frequencies (3000 Hz and above) Willingness to use bimodal stimulation (i.e. a cochlear implant on one ear and a hearing aid on the contralateral ear) through at least 6-months postactivation. English spoken as the primary language. Exclusion Criteria: Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age). Preoperative aided HINT sentence score less than or equal to 50% in the ear to be implanted Ossification, absence of cochlear development or any other cochlear anomaly that might prevent complete insertion of the electrode array. Hearing loss of neural or central origin (e.g., deafness due to lesions on the acoustic nerve or central auditory pathway). Active middle-ear infection. Unwillingness and/or inability of the candidate to comply with all investigational requirements including, but not limited to, study protocol and surgical procedure.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Colin Driscoll, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Evaluation of a Revised Indication for Determining Adult Cochlear Implant Candidacy

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