Efficacy of Amplification With Hearing Aids for Tinnitus Relief

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2023-12-31

Brief Summary

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This study evaluates the treatment efficacy of tinnitus in people with mild hearing loss. One-third of participants will use hearing aid, one-third of participants will use customized music, while the other one-third participants will receive no treatment (waiting list control).

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Detailed Description

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Acoustic stimulation could induce plastic changes in the auditory cortex, and tinnitus mechanisms have been viewed as a negative consequence of neural plasticity in the central nervous system after peripheral aggression. Cortical changes (neural activity in the deafferented cortical area was reduced but the adjacent frequencies of the hearing loss region activated more extensive cortical areas) occur after sensorineural hearing loss, while exposure to an acoustically enriched environment or using hearing aids may minimize or reverse the plastic tonotopic map changes in the auditory cortex. The use of hearing aids in tinnitus management for people with significant hearing loss will always be associated with an improvement in hearing handicap and quality of life, and that complicates the interpretation of how much hearing aids specifically affect tinnitus. Thus studies on tinnitus patients with mild hearing loss could be illuminating, and this population will be targeted in the present study.

Conditions

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Tinnitus, Subjective Hearing Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Waiting list control group

There will be no treatment for 12 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Hearing aid group

Participants will receive amplification with hearing aids. Bilateral open-fit hearing aids will be fitted. Participants will be required to use the hearing aids for at least 2 hours daily for 12 months.

Group Type EXPERIMENTAL

Amplification with hearing aid

Intervention Type DEVICE

Use of hearing aids

Customized music group

Customized music according to participants hearing level will be made available in an iPod. The iPod will deliver ear-specific therapeutic sound for asymmetrical hearing profile. Participants will have to listen to the therapeutic sound at a comfortable volume for two hours daily for 12 months.

Group Type ACTIVE_COMPARATOR

Customized music

Intervention Type DEVICE

Customized music delivered via an iPod

Interventions

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Amplification with hearing aid

Use of hearing aids

Intervention Type DEVICE

Customized music

Customized music delivered via an iPod

Intervention Type DEVICE

Other Intervention Names

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Hearing aid group

Eligibility Criteria

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Inclusion Criteria

* 18 years old or above
* can provide written informed consent
* have a diagnosis of subjective tinnitus, i.e., the tinnitus can only be heard by the patient and there is no acoustic source
* a tinnitus duration of more than one year
* have pure-tone average between 20 and 40 dB HL
* have bilateral symmetrical hearing loss (i.e. difference less than 15 dB)
* have at least a medium level of distress caused by tinnitus as indicated with total scores above 30 on the TQ-CH
* are committed to complete the 12-month follow-up

Exclusion Criteria

* objective tinnitus, i.e. tinnitus produced by an internal acoustic source activating the cochlea and can be heard by another person
* received other forms of tinnitus treatments within three months before the baseline assessment session
* any history suggestive of psychiatric illness
* psychological distress or depression as indicated with total scores at or above 15 on the Cantonese HADS
* current hearing aid users
* inability to complete the study as revealed by the medical reports

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes