Although ASHA continues to maintain that the best model of hearing
health care features audiologists and consumers collaborating on treatment
options, it recognizes instances where that model can be modified. There may be
advantages to making hearing aids directly available to some consumers with
mild hearing loss. Less costly over-the-counter (OTC) hearing aids could serve
as an early gateway for users with mild hearing loss to explore whether they
could eventually adapt to hearing technology without significant financial
outlay. It is already the case that consumers with perceived mild hearing loss
can seek amplification on their own, without professional involvement, by
purchasing unregulated personal sound amplification products or other products
and devices that are indirectly marketed for hearing loss.
Consequently, ASHA will support proposed legislation related to OTC
hearing aids for mild hearing loss only, given that the following provisions are
included in the legislation:
Require the FDA to
- establish limited gain and output thresholds for
these hearing aids;
- ensure that OTC hearing aids are available for
- establish a means for collecting information on
consumer safety and other potential complaints;
- require labeling that strongly recommends
seeking audiologic diagnostic and rehabilitative services; and
- require labels that provide consumers with
warning signs for conditions that require medical treatment.
Ensure that current insurance coverage of
hearing aids is not undermined. Currently, some states mandate that insurers,
including Medicaid, provide coverage for hearing aids for adults; the U.S.
Department of Veterans Affairs and the Federal Employee Health Benefits Plans also
provide coverage for hearing aids. Any new OTC model should not be seen as a
substitute for hearing aid benefits under third party plans.
Furthermore, ASHA strongly encourages Senator Chuck
Grassley (R-IA) and Senator Elizabeth Warren (D-MA) to take a more holistic
approach to access to and affordability of hearing aids. Although we can support the creation of a new OTC
hearing aid category for mild hearing loss, we believe that this represents
only part of the solution. A parallel effort must be undertaken to ensure the
establishment of both public and private insurance coverage for patients with
hearing loss who do not benefit from an OTC device. These additional categories
of services would include coverage of the professional auditory rehabilitation services
of an audiologist that would allow a person with hearing loss to maximize their
communication abilities with amplification. Without meaningful coverage of all
hearing health care services for all individuals with hearing loss, there is a
high probability that these individuals will inappropriately self-prescribe OTC
devices and fail to receive appropriate care—thereby, not achieving the
sufficient benefit from OTC hearing aids.
ASHA will work with other stakeholders to encourage
the Centers for Medicare & Medicaid Services and private health plans to
achieve these goals. We urge Congress to review and develop legislation to
address Medicare and Medicaid coverage of audiologic services and hearing aids
simultaneously with consideration of a new category of OTC hearing aids.
For more information, contact Ingrida Lusis, ASHA's director of federal
and political advocacy, at [email protected].