Investigating the benefit of hearing aids in adults with tinnitus and mild hearing loss

A randomized controlled trial assessing the effectiveness of hearing aids (intervention setting) compared to hearing aids (placebo setting) in reducing tinnitus for adults with mild hearing loss

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN31221437

Enrollment

128

Registered

2021-06-02

Start date

2021-04-19

Completion date

Unknown

Last updated

2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tinnitus and mild hearing loss Ear, Nose and Throat Tinnitus, hearing loss, unspecified

Interventions

Randomisation treatment allocation will be on a 1:1 basis using a sequentially randomised dynamic adaptive algorithm via a secure database. One group of participants will receive a he

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 years or over with a clinical diagnosis of tinnitus with mild sensorineural hearing loss* unilaterally or bilaterally, hearing level (4FA) measured no more than 6 months prior to tinnitus assessment appointment 2. Willing to trial hearing aid/s only as a tinnitus management option 3. Capable of providing written informed consent 4. Ability to communicate in English 5. Ability to understand and complete the English versions of the questionnaires *For the purposes of this trial, mild hearing loss is defined as hearing threshold between 26 and 40dBHL when averaged at the four frequencies of 0.5, 1, 2 and 4kHz as per the World Health Organisation definition (2019) and other studies (Donahue et al, 2010; Ferguson et al, 2017; Mathers et al, 2000). This measure is referred to in this protocol as “4FA”

Exclusion criteria

Exclusion criteria: 1. Tinnitus of a medically treatable origin 2. Hearing loss of a medically treatable origin 3. Unilateral tinnitus reported in the ear with normal hearing 4. Hearing loss (4FA) of 41dB or greater unilaterally 5. Those requiring other tinnitus management options 6. Previous use of a hearing aid, combination device or behind the ear sound generator 7. GAD-7 score of 8 or more and/or PHQ-9 score of 10 or more, suggesting more complex mental health needs

Design outcomes

Primary

Measure	Time frame
The effects of tinnitus measured using the tinnitus functional index (TFI) at baseline, 8 weeks and 6 months post hearing aid fitting	—

Secondary

Measure	Time frame
1. Mental and emotional health disorders screened using the PHQ-9 at baseline, 8 weeks and 6 months post hearing aid fitting 2. Generalised anxiety disorder and severity of anxiety screened using the GAD-7 at baseline, 8 weeks and 6 months post hearing aid fitting 3. General quality of life measured using the ED-5L-3D at baseline, 8 weeks and 6 months post hearing aid fitting 4. Hearing aid usage data collected at 8 weeks and 6 months post hearing aid fitting	—

Measure

Time frame

1. Mental and emotional health disorders screened using the PHQ-9 at baseline, 8 weeks and 6 months post hearing aid fitting 2. Generalised anxiety disorder and severity of anxiety screened using the GAD-7 at baseline, 8 weeks and 6 months post hearing aid fitting 3. General quality of life measured using the ED-5L-3D at baseline, 8 weeks and 6 months post hearing aid fitting 4. Hearing aid usage data collected at 8 weeks and 6 months post hearing aid fitting

—

Countries

United Kingdom, Wales

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026