None listed
Conditions
Brief summary
The primary goal for this study is to assess the clinical performance of the Tinnitus Sound Support feature of the Oticon "More" hearing aid. It will examine if the hearing aid achieves the intended purpose of providing temporary relief from tinnitus. The study will also assess if the hearing aids achieve the intended purpose of helping hearing. Four different listening programs combining sound amplification and tinnitus therapy sounds will be provided to try.
Interventions
The intervention in this study is the fitting of hearing aids. These hearing aids have an option of turning on tinnitus therapy sounds (e.g. white noise, pink noise) these sounds resemble a constant rain sound and provide relief (masking) from tinnitus. The study will investigate whether different settings on Oticon "More" hearing aids (amplification and/or therapy sounds) provide relief as indexed by questionnaires. The settings and methods are described in a detailed protocol attached. The
The intervention in this study is the fitting of hearing aids. These hearing aids have an option of turning on tinnitus therapy sounds (e.g. white noise, pink noise) these sounds resemble a constant rain sound and provide relief (masking) from tinnitus. The study will investigate whether different settings on Oticon "More" hearing aids (amplification and/or therapy sounds) provide relief as indexed by questionnaires. The settings and methods are described in a detailed protocol attached. The materials that will be used in the intervention will include a pair of appropriately fitted hearing aids tuned to the participants hearing loss along with batteries and supplies to maintain the use of the hearing aids. Participants will be provided with counselling as to how to use the aids and maintain them. Following screening of suitability and assessment of hearing and tinnitus the aids will be fit according to best practice including the measurement of real-ear-measures to ascertain acoustic suitability. The participant will be followed for further tuning of the aids and to complete the protocol steps. The hearing aids will be fit by AP Grant Searchfield and a research fellow/audiologist (TBD). AP Searchfield is an audiologist with 30 years of hearing aid fitting experience.The hearing aids will be provided face to face, some follow support will be offered over email/phone if needed between scheduled appointments. The study consists of three clinical visits, where visit 1 comprises of a tinnitus and hearing assessment and a hearing aid fitting (90 minutes). Following this, participants will wear the devices for a three-month trial, in which a clinical follow-up visit (30 mins) is scheduled after three weeks, plus the option of an additional follow-up if needed. These one-or-two follow-ups are to adhere with normal clinical practice and to adjust the program order to suit your preference. Visit 3 is a follow-up and final visit. Participants will be requested to wear the hearing aids for a minimum 8 hours per day (total, not consecutive).
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria were: Adults aged 18 years or above; Chronic tinnitus (at least 6 months since onset); New and experienced HA users with a symmetric slight (16 dB HL) to moderately severe (70 dB HL) binaural symmetric (PTA4 difference between ears of 15 dB or less) sensorineural or mixed flat or sloping hearing loss; HA fitting level for the 60- or 85-dB speaker and domes, or custom moulds including all types and configurations of hearing loss; Scores in the range of ‘Normal to Severe’ in each of the three categories on the Depression Anxiety and Stress Scale – 21 Items (DASS 21).
Exclusion criteria
Absence of tinnitus or hearing loss. A score of ‘Extremely Severe’ in any one of the three categories of the DASS 21; Objective, pulsatile tinnitus.
Outcome results
None listed