Intricon Self-Fitting Technology for Over-The-Counter Hearing Aids Clears Clinical Trial Milestone
30 Setembro 2021 - 5:05PM
Intricon Corporation (NASDAQ: IIN), a joint development
manufacturer of micromedical technology for use in interventional,
implantable, and body-worn medical devices, announced that it has
achieved a critical milestone in the clinical study of its
proprietary software that will allow people to self-fit hearing
aids that are sold over-the-counter at retail stores and online.
Summative Usability Validation has been completed, which
demonstrates that users can safely and correctly use the Intricon
self-fitting technology, and the clinical trial of the software can
move forward. The milestone is meaningful in the progression of the
study, which is expected to be complete by the end of 2021, in time
for the anticipated FDA guidance that will allow consumers to
purchase and program hearing aids themselves, at a lower cost and
without the need for an audiologist.
The study is being conducted by Intricon research partner
clEAR/Amptify, involving 120 participants with mild to moderate
hearing loss. The software will allow consumers to test their
hearing and set their hearing aids accordingly using a mobile
device.
The trial is part of the company’s plan to secure FDA clearance
in time to meet the expected market demand for over-the-counter
hearing aids. Last month, President Biden ordered the FDA to
produce regulations by mid-November for over-the-counter (OTC)
purchases of hearing aids without a prescription or a visit to an
audiologist.
In the meantime, new hearing devices have entered state markets,
including the HearX Lexie Lumen, now in selected states, that
features Intricon hardware, firmware and wireless technology. The
Lexie Lumen is sold in Walgreen’s stores and online for $799 per
pair, compared to the average $4,800 per pair for hearing aids that
require audiologist assistance.
“Advanced self-fitting software will be imperative for when
hearing aids are available to the mass market,” said Scott Longval,
CEO of Intricon, adding that an “ecosystem of care” must be
developed to fully support the consumer experience and success with
OTC hearing aids. This ecosystem includes the right combination of
the latest software, hardware, online self-service for fittings and
settings, partnerships for branding, and retail distribution.
“While we wait for the FDA to move forward, we’re continuing to
advance the technology to make OTC hearing aids easy to use for the
3 out of 4 people in the U.S. with mild to moderate hearing loss
who are not yet using hearing devices.”
About Intricon CorporationIntricon is
a Joint Development Manufacturer that integrates micromedical
components and assemblies to advance technology across a range of
device platforms for global
customers. Intricon approaches each engagement with an
all-in commitment, working with customers every step of the way -
from the earliest idea stages to ongoing production - in order to
advance program performance and deliver results. With a focus on
key device platforms, Intricon helps advance clinical
outcomes by always looking ahead with proactive support and
resources through integration of its core
competencies. Intricon has facilities in the United
States, Asia and Europe. The company's common stock
trades under the symbol "IIN" on the NASDAQ Global Market.
Media ContactBeth LaBreche(612)
578-2834 beth@labreche.com
Investor ContactLeigh Salvo(415)
937-5404 investorrelations@intricon.com
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