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

INTERVENTION: 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 hearing aid set with amplification (intervention hearing aid/s) and the other group will receive a hearing aid fitted in the same way but without amplification (placebo hearing aid/s). Participants will be expected to wear the hearing aid/s every day for a 6‐month period. They will be asked to complete questionnaires, at the beginning of the trial, at an 8‐week follow up and again at 6 months. CONDITION: Tinnitus and mild hearing loss ; Ear, Nose and Throat ; Tinnitus, hearing loss, unspecified PRIMARY OUTCOME: The effects of tinnitus measured using the tinnitus functional index (TFI) at baseline, 8 weeks and 6 months post hearing aid fitting SECONDARY OUTCOME: ; 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; 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”