Efficacy of Amplification With Hearing Aids for Tinnitus Relief

Education University of Hong Kong

Status: Completed

Conditions: Tinnitus, Subjective; Hearing Impairment

Treatments: Device: Amplification with hearing aid; Device: Customized music

Study type: Interventional

Funder types: Other

Identifiers

NCT03716544

RGC18100117

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 3 patient groups

Waiting list control group

No Intervention group

Description:

There will be no treatment for 12 months.

Hearing aid group

Experimental group

Description:

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.

Treatment:

Device: Amplification with hearing aid

Customized music group

Active Comparator group

Description:

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.

Treatment:

Device: Customized music