Age-related hearing loss presents a significant national challenge due to its high
prevalence and significant quality-of-life consequences. Although hearing aids (HAs) are
the primary choice for managing age-related hearing loss, their adoption rate remains
low. One commonly reported reason for not adopting HAs is the financial and physical
barriers associated with traditional hearing healthcare, which involves multiple visits
to licensed professionals (such as audiologists) for diagnosis and a lengthy process of
fitting and fine-tuning prescription HAs. This traditional service-delivery model is
referred to as the AUD service model.
Additionally, a variety of technologies and features have been implemented in HAs,
including multi-channel wide dynamic range compression, directional microphones, noise
reduction algorithms, and wireless functionality. These technologies have evolved from
basic algorithms into more sophisticated and complex designs. The high-end technologies
and features often make HAs more expensive, further exacerbating the accessibility and
affordability issues of traditional hearing healthcare.
In recent years, over-the-counter (OTC) HAs have emerged as an alternative to address
some of the affordability and accessibility issues of the AUD service. This
direct-to-consumer model enables users to self-determine hearing loss, self-fit OTC HAs,
and self-manage the device without the need for professional support. This
direct-to-consumer model is referred to as the OTC service model. Additionally, it has
been advocated that a hybrid service model, where professionals fit OTC HAs (referred to
as the OTC+ service model), could offer affordable and quality amplification
interventions.
Previous clinical trials have shown that the OTC service model yields outcomes comparable
to the AUD service model. Furthermore, prior research has found no statistically
significant or clinically important differences in patient outcomes between high-end and
low-end HAs. However, no prior research has systematically examined the effectiveness of
HA fitting service models and HA technology levels in the same study. Additionally, no
prior research has investigated the patient outcomes of the OTC+ service model.
The objective of the study is to determine the effect of HA fitting services (AUD, OTC+,
and OTC) and technology levels (high-end and low-end) on patient outcomes. This is a
two-site randomized controlled trial. Participants will be randomly assigned to one of
six parallel arms, which are factorial combinations of three service models (AUD, OTC+,
and OTC) and two HA technology levels (high-end and low-end). Baseline measures will be
administered before HA fitting and patient outcomes will be assessed six to seven weeks
post-HA fitting.