Efficacy of Hearing-aid Treatment for Patients With Tinnitus and Co-existing Hearing Loss

Study Overview
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Brief Summary
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Considering the extent to which HAs play a role in sound perception and residual hearing preservation among patients with tinnitus and co-existing HL remains a lack of compelling extensive evidence, investigators designed this single-blind, 6-months randomized, controlled trial with two parallel groups. One is the HA treatment group, and the other is the waiting list control (WLC) group which receives no interventions during this period.

Detailed Description
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In clinical practice, chronic subject tinnitus poses an important challenge. This condition can negatively affect an individual's emotional and functional well-being. In most cases, tinnitus is highly associated with hearing impairment, particularly in cases of high-frequency sensorineural hearing loss (SNHL). The occurrence of tinnitus in patients with HL is one of the most prevalent sensory disabilities, causing a deleterious effect on patients' lives. Nowadays, the mild to moderate SNHL can be effectively managed with a fitting hearing aid (HA) by providing sound amplification, and several findings suggest that the HA may also be helpful for people with tinnitus. Nevertheless, in terms of the effects of HA use for residual hearing protection for patients with tinnitus and co-existing hearing loss, inadequate attention is still paid by medical personnel, and relevant evidence remains preliminary at this point in time. To assess the full extent of tinnitus patients, investigators need to carry out a series of tests, including hearing assessment and psychometric tests. Pure tone audiometry (PTA) and otoacoustic emission (OAE) tests are used to calculate the average hearing thresholds and the outer hair cell function, while the Tinnitus hazard Index (THI), the Visual Analogue Scale (VAS), the Hospital Anxiety and the Depression Scale (HADs) and the Athens Insomnia Scale-8 (AIS-8) questionnaires were for patients' psychology status. Investigators hypothesize that in patients with tinnitus and hearing loss, HA intervention results in better conditions of tinnitus and lower hearing threshold reduction. Here investigators planned to enroll patients into two groups, the HA and non-HA (served as the control) intervention patients.

Official Title
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Efficacy of Hearing-aid Treatment on Sound Perception and Residual Hearing Preservation for Patients With Tinnitus and Co-existing Hearing Loss: a Randomized Controlled Trial

Conditions
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Tinnitus, Subjective, Hearing Loss, High-Frequency

Intervention / Treatment
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* Device: Hearing aids


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged older than 18 years old and less than 70 years; Chronic (>6 months) subjective tinnitus, unilateral or bilateral; Diagnosed with a high-frequency SNHL; Be available for six months after starting the study to complete the follow-up questionnaires; Readiness to participate in the study and sign the informed consent. Be covered by public health insurance and eligible for reimbursement. Exclusion Criteria: Objective tinnitus; Conductive HL; Unstable medical history that limits participation; Undergoing any other concurrent treatments on tinnitus or HL; Having used HAs in the past 1 year; Unwilling or unable to use HAs daily; Alcohol or drug abuse; Unable to read or write.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HA treatment group<br>Participants in the treatment group are required to wear the HAs for at least 3 hours per day, with 24 days per month. Additionally, they will receive regular counseling and lifestyle education from their physicians. | Device: Hearing aids<br>* As for screening the hearing and tinnitus testing, the measure typically comprises PTA, SRS, DPOAE, and several widely accepted standardized tinnitus questionnaires, including the THI for tinnitus severity and VAS for tinnitus loudness.<br>|
| No Intervention: non-HA treatment group<br>Non-HA treatment group is a waiting list control group (WLC) in which participants will receive the intervention after the waiting period has passed. They will only receive regular counseling and lifestyle education from their physicians in this waiting period. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tinnitus handicap inventory (THI) | The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus. | 3 months from baseline | 
| tinnitus handicap inventory (THI) | The THI is a self-administered test, including 25 questions with grades four categories of tinnitus severity: slight corresponding to a score of 0-16, mild (18-36), moderate (38-56), severe (58-100). The higher the score the more severe the tinnitus. | 6 months from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| speech recognition score (SRS) test | The list consists of 25 monosyllabic words, and each word is rated on a 4-point scale with a total score of 100. A higher score indicates a better level of auditory comprehension and speech recognition. | 3 months from baseline | 
| speech recognition score (SRS) test | The list consists of 25 monosyllabic words, and each word is rated on a 4-point scale with a total score of 100. A higher score indicates a better level of auditory comprehension and speech recognition. | 6 months from baseline | 
| pure tone audiometry (PTA) | PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level. | 3 months from baseline | 
| pure tone audiometry (PTA) | PTA is performed to calculate the average hearing thresholds obtained at multiple frequencies in dB hearing level. | 6 months from baseline | 
| otoacoustic emission (OAE) | OAE test could help evaluate the mechanism of tinnitus since it determines whether or not the outer hair cells are overexcited or damaged. | 3 months from baseline | 
| otoacoustic emission (OAE) | OAE test could help evaluate the mechanism of tinnitus since it determines whether or not the outer hair cells are overexcited or damaged. | 6 months from baseline | 
| the Hospital Anxiety and Depression Scale (HADs) | The HADs consist of 14 items which are equally divided into two dimensions: a depression sub-scale (HADs-D) and an anxiety sub-scale (HADs-A). The grades are valued by scoring: negative (0-7), positive (8-21). | 3 months from baseline | 
| the Hospital Anxiety and Depression Scale (HADs) | The HADs consist of 14 items which are equally divided into two dimensions: a depression sub-scale (HADs-D) and an anxiety sub-scale (HADs-A). The grades are valued by scoring: negative (0-7), positive (8-21). | 6 months from baseline | 
| the Athens Insomnia Scale-8 (AIS-8) | The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24). | 3 months from baseline | 
| the Athens Insomnia Scale-8 (AIS-8) | The AIS comprises eight items that commonly measure difficulties in falling asleep or maintaining sleep to quantify the presence of insomnia. The higher the AIS score, the lower the sleep quality and mental status. The AIS identifies three types of sleep disorders: no insomnia (score below 4), suspicious (4-6), and insomnia (score between 7-24). | 6 months from baseline |