Tinnitus Suppression for Cochlear Implant Recipients

Tinnitus Clinical Trial

Official title:

Evaluation of Tinnitus Suppression for Cochlear Implant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794623
• Other study ID #: CRC 5583
• Status: Completed
• Phase: N/A
• Start date: October 18, 2014
• Est. completion date: June 8, 2018

Study information

• Verified date: July 2021
• Source: The Hearing Cooperative Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tinnitus is the perception of sound in the absence of an external sound. Prevalence in the general population is 10 to 15%, with tinnitus severely impacting quality of life in 1-2 percent of the population. Tinnitus therapy is based on counselling, cognitive and behavioural therapies in combination with sound therapies which mostly rely on masking.

For cochlear implant candidates, the ability to use hearing aids and maskers is limited by the degree of their hearing loss. Reports of tinnitus prevalence in this group range from 67 to 100% with a mean of 80%.

In cochlear implant (CI) recipients, tinnitus suppression primarily occurs during active use of the cochlear implant system. In some CI recipients residual inhibition of tinnitus occurs when the implant is switched off. While the benefits of CI implantation on tinnitus are well documented, there is a group of recipients where tinnitus remains a concern in the implanted ear post-operatively.

The primary aim of this study is to investigate the benefits of using tinnitus masking via a CI sound processor that optimises tinnitus suppression with minimal annoyance to the user. Furthermore a questionnaire will be employed to capture the prevalence, degree and nature of tinnitus in recipients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 8, 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age or older

2. Freedom or CI500 series implant

3. At least 3 months experience with the cochlear implant

4. Native speaker in the language used to assess speech perception performance

5. Willingness to participate in and to comply with all requirements of the protocol

6. Self-reported tinnitus in the implanted ear

7. Reside local to investigational site

Exclusion Criteria:

1. Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and test including MRI

2. Additional handicaps that would prevent participations in evaluations

3. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• Tinnitus masking
Tinnitus masking via CI system

Locations

Country	Name	City	State
Australia	The HEARing CRC	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
The Hearing Cooperative Research Centre	Cochlear, Royal Victoria Eye and Ear Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Severity Questionnaire	Tinnitus severity questionnaire using Visual Analog Scale	Testing over 6 months
Primary	Word recognition scores in quiet	Monosyllabic word scores in quiet	Testing over 6 months
Primary	Speech recognition scores in noise	Sentence recognition scores in noise	Testing over 6 months
Secondary	Degree of handicap as a result of tinnitus	Tinnitus Handicap Questionnaire used to capture degree of overall handicap as a result of tinnitus	Testing over 6 months