Efficacy of Amplification With Hearing Aids for Tinnitus Relief

Efficacy of Amplification With Hearing Aids for Tinnitus Relief: a Randomized Controlled Trial

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).

Study Overview

• Status: Completed
• Conditions: Tinnitus, Subjective; Hearing Impairment
• Intervention / Treatment: Device: Amplification with hearing aid; Device: Customized music

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • The Education University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Waiting list control group; There will be no treatment for 12 months.
Experimental: 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.	Device: Amplification with hearing aid; Use of hearing aids; Other Names: Hearing aid group
Active Comparator: 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.	Device: Customized music; Customized music delivered via an iPod

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Tinnitus Functional Index (Chinese version) (TFI-CH)	TFI-CH is a 25-item self-administered questionnaire which assesses eight domains of tinnitus impact: intrusiveness; sense of control; cognitive; sleep; auditory; relaxation; quality of life (QoL); emotion. The total TFI score ranges 0 - 100, the higher score is indicative of greater problem with tinnitus.	Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Tinnitus Questionnaire (Chinese version) (TQ-CH) scores	The TQ-CH is a 52-item questionnaire which assesses five dimensions of tinnitus complaint: emotional distress; auditory perceptual difficulties; intrusiveness; sleep disturbance; and somatic complaints. The total TQ score ranges 0 - 104, the higher score is indicative of greater problem with tinnitus.	Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
The Tinnitus Handicap Inventory (Chinese version) (THI-CH) scores	The THI-CH is a reliable 25-item self-administered Chinese QoL tool that quantifies the impact of tinnitus on daily living. The total THI score ranges 0 - 100, the higher score is indicative of greater tinnitus handicap.	Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Self-rated Visual Analogue Scale (VAS) on tinnitus loudness	The subjects will be asked to rate the perceived loudness of their tinnitus on VAS, with "inaudible" (scale rating value = 0) and "very loud" (scale rating value = 100) as reference points for the ends of the scale. The higher rating is indicative of louder tinnitus.	Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.
Tinnitus loudness matches at the tinnitus frequency and at 1000 Hz	Tinnitus loudness matches will be done according to Vernon and Meikle's procedure	Change from baseline values at 3 months, 6 months and 12 months after the first day of treatment will be measured.
The Chinese Hospital Anxiety and Depression Scale (HADS)	The Chinese HADS is a 14-item questionnaire that consists of two subscales that measure anxiety and depression. It serves as an outcome measure targeting psychological and mental health effects.	Change from baseline value at 3 months, 6 months and 12 months after the first day of treatment will be measured.

Collaborators and Investigators

• Sponsor: Education University of Hong Kong
• Collaborators: Chinese University of Hong Kong
• Investigators: Principal Investigator: Anna CS KAM, AuD, The Education University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Hearing Loss; Tinnitus; Amplification; Sound Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Tinnitus
• Other Study ID Numbers: RGC18100117

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No