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Completed

NCT Number: NCT02794623

Tinnitus Suppression for Cochlear Implant Recipients

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.

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Key information

Conditions

Tinnitus Ear Diseases Hearing Disorders Hearing Loss Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The HEARing CRC

Melbourne, Victoria, 3002, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age or older
  • Freedom or CI500 series implant
  • At least 3 months experience with the cochlear implant
  • Native speaker in the language used to assess speech perception performance
  • Willingness to participate in and to comply with all requirements of the protocol
  • Self-reported tinnitus in the implanted ear
  • Reside local to investigational site

Exclusion criteria

  • Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and test including MRI
  • Additional handicaps that would prevent participations in evaluations
  • Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the study

Treatment and study plan

Tinnitus masking

Device

Tinnitus masking via CI system

Primary outcomes

  1. Tinnitus Severity Questionnaire

    Time frame: Testing over 6 months

    Tinnitus severity questionnaire using Visual Analog Scale

  2. Word recognition scores in quiet

    Time frame: Testing over 6 months

    Monosyllabic word scores in quiet

  3. Speech recognition scores in noise

    Time frame: Testing over 6 months

    Sentence recognition scores in noise

Secondary outcomes

  1. Degree of handicap as a result of tinnitus

    Time frame: Testing over 6 months

    Tinnitus Handicap Questionnaire used to capture degree of overall handicap as a result of tinnitus

Sponsors and collaborators

Lead sponsor

The Hearing Cooperative Research Centre

Other

Collaborators

  • Cochlear
  • Royal Victoria Eye and Ear Hospital

Registry information

Official study title

Evaluation of Tinnitus Suppression for Cochlear Implant Recipients

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jun 9, 2016
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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