Cost-effective Hearing Aid Delivery Models

Age-related hearing loss is a substantial national problem due to its high prevalence and
significant psychosocial consequences. However, the adoption rate of the primary intervention
of age-related hearing loss, i.e., hearing aids (HAs), is quite low (15-30%). One of the most
commonly reported reasons that people do not seek HA intervention is the high cost of devices
plus the costly professional (e.g., audiologist) fitting services. This type of
intervention—HAs fitted using the audiologist-based service-delivery model (AUD model)—is
considered to be the best practice for management of adults with hearing loss. Because the
AUD model is unaffordable for many Americans who need HAs (64%), there has been increased
advocacy for a variety of over-the-counter service-delivery models (OTC models). In 2010, 1.5
million Americans purchased amplification devices via OTC models to compensate for their
impaired hearing.

Although the OTC models are gaining popularity and are regarded as an important option for
promoting accessible and affordable hearing healthcare, major questions remain unanswered.
Specifically, the OTC models proposed to date rely on assumptions that patients can
appropriately self-diagnose, self-select, self-fit and (in some cases) self-adjust
amplification. However, there is little data to support any of the underlying assumptions. A
recent study suggests that the AUD model yields better outcomes than the OTC models, but it
is unclear if a rigorous randomized controlled trial can replicate this result. Furthermore,
if there are outcome differences between AUD and OTC models, it is unknown if the clinical
improvement in outcomes will be offset by the improved value (outcome relative to cost), or
if it is possible to identify appropriate candidacy for each model to ensure optimal patient
care for all. Finally, no prior research has investigated if "hybrid" service-delivery
models, in which professionals provide streamlined services to fit OTC amplification devices,
offer affordable and quality amplification interventions as has been recently advocated.

The overall goal of this project is to characterize the differential effect of
service-delivery models on provision of amplification so that accessible and affordable
hearing healthcare can be facilitated. The central hypothesis is that an OTC model or a
hybrid model is a viable solution for many, but not all, patients with
mild-to-moderately-severe age-related hearing loss. Since the optimal OTC model and the
definition of OTC amplification device is still in question, the investigators propose to
focus on the role of professional services in the provision of cost-effective amplification.
To answer the research questions, the investigators have designed procedures to implement an
OTC model, in which research participants will take the full initiative and responsibility
for learning and using amplification. The investigators then systematically add professional
patient-centered services (e.g., device orientation and counselling) to the OTC model to
create a hybrid model. Finally, the investigators add device-centered services (e.g., device
adjustment under the guidance of real-ear measures) to the hybrid model to create an AUD
model that serves as the control. The investigators will electronically configure HAs to
simulate OTC devices (e.g., fixed frequency response) and will use the same devices as HAs in
the AUD model. The investigators will conduct a two-site, randomized controlled study to
document the intervention outcomes of these four models using a test battery that consists of
behavioral and self-report measures. Several patient-centered variables, including degree and
configuration of hearing loss, cognitive functions, and personality will be measured and used
as candidacy predictors.

Aim 1. To determine the outcome, value, and candidacy of the OTC model relative to the AUD
model. The OTC model excludes professional services and represents the simplest form of the
OTC model (referred to as the OTC model). The AUD model, in which professionals will use a
core set of best practices to fit entry-level HAs, likely represents the most cost-effective
AUD model (referred to as the AUD model). Based on the preliminary data, it is hypothesized
that the OTC model will yield poorer outcomes than the AUD model. The value, which will be
compared using cost-effectiveness analysis, is less predictable because the model
hypothesized to yield better outcomes is more expensive. The investigators further
hypothesize that at least some patient-centered variables will be predictive of outcome
difference between the models and thus can be used to help decide which model a patient
should choose.

Aim 2. To determine the outcome, value, and candidacy of the hybrid model. The hybrid model
is the OTC-Plus model, in which professionals provide streamlined services to fit OTC
devices. It is hypothesized that the outcomes of the hybrid model will be poorer than the AUD
model but better than the OTC model. Because the investigators are proposing a total of three
levels of service (including no service), achieving this aim will also allow us to document
the effect of professional service on outcome and value. It is hypothesized that professional
services will contribute to outcomes, and that each increase in the level of professional
service will lead to an incremental improvement in outcomes. The value of each level of
service in the hybrid model is less predictable. It is also hypothesized that at least some
patient-centered variables will predict equal outcomes for some individuals across hybrid and
AUD models.

Inclusion Criteria:

- adult-onset, bilateral, mild-to-moderately severe sensorineural hearing loss

- no previous hearing aid experience

Exclusion Criteria:

- Non-native speaker of English