Background: Whereas hearing aids have long been considered effective for providing relief from
tinnitus, controlled clinical studies evaluating this premise have been very limited.
Purpose: The purpose of this study was to systematically determine the relative efficacy of
conventional receiver-in-the-canal hearing aids (HA), the same hearing aids with a
sound generator (HA+SG), and extended-wear, deep fit hearing aids (EWHA), to provide
relief from tinnitus through a randomized controlled trial. Each of these ear-level
devices was a product of Phonak, LLC.
Research Design: Participants were randomized to HA, HA+SG, or EWHA and wore bilaterally fit devices
for about 4 months. Fittings, adjustments, and follow-up appointments were conducted
to comply with company guidelines and to ensure that all participants attended appointments
on the same schedule. At 4–5 months, participants returned to complete final outcome
measures, which concluded their study participation.
Study Sample: Participants were 55 individuals (mean age: 63.1 years) with mild to moderately-severe
hearing loss who: (a) did not currently use hearing aids; (b) reported tinnitus that
was sufficiently bothersome to warrant intervention; and (c) were suitable candidates
for each of the study devices.
Data Collection and Analysis: The primary outcome measure was the Tinnitus Functional Index (TFI). Secondary outcome
measures included hearing-specific questionnaires and the Quick Speech in Noise test
(QuickSIN). The goal of the analysis was to evaluate efficacy of the EWHA and HA+SG
devices versus the HA standard device.
Results: There were 18 participants in each of the HA and EWHA groups and 19 in the HA+SG
group. Gender, age, and baseline TFI severity were balanced across treatment groups.
Nearly all participants had a reduction in tinnitus symptoms during the study. The
average TFI change (improvement) from baseline was 21 points in the HA group, 31 points
in the EWHA group, and 33 points in the HA+SG group. A “clinically significant” improvement
in reaction to tinnitus (at least 13-point reduction in TFI score) was seen by 67%
of HA, 82% of EWHA, and 79% of HA+SG participants. There were no statistically significant
differences in the extent to which the devices reduced TFI scores. Likewise, the hearing-specific
questionnaires and QuickSIN showed improvements following use of the hearing aids
but these improvements did not differ across device groups.
Conclusions: There is insufficient evidence to conclude that any of these devices offers greater
relief from tinnitus than any other one tested. However, all devices appear to offer
some improvement in the functional effects of tinnitus.
acoustic stimulation - hearing - outcomes - randomized controlled trial - research
- tinnitus
