InnerScope
Hearing Technologies Receives its FDA Class I and II
Importers Clearance on their ALPHA Brand Hearing Aid Device
Products
The Company will offer its own
line of FDA-cleared hearing aid devices through its
www.nohasslehearing.com
eCommerce store.
ROSEVILLE, CA. -- May
30, 2018 -- InvestorsHub NewsWire -- (OTCQB:
INND) Hearing Technologies
InnerScopeannounced
today it has been awarded its FDA importers registration clearances
from the FDA for its ALPHA line of hearing aid devices which will
be sold online through its www.nohasslehearing.com
website.
InnerScope
received,
under the FDA code of Federal Regulations a Class I certificate,
for its air-conduction hearing aid devices and a Class II
certificate for its wireless air-conduction
hearing aid devices. This gives the Company
the legal right to import, market and sell the ALPHA branded label
hearing aid devices in the United States. These FDA Class I and
Class II clearances is part of the Company's
overall strategic plan to continue to expand its footprint within
the U.S hearing aid market by creating strategic partnerships and
exclusive supply agreements with hearing aid suppliers and
manufactures around the world to bring unique and affordable
hearing technology via direct to consumers for the U.S and global
markets.
The
ALPHA hearing aid series are receiver-in-canals (RICs) with a very
small discreet and comfortable compact design with Bluetooth Low
Energy (BLE) wireless technology (for direct connection to external
Bluetooth-enable devices) with a user app for added control and
personalizing the hearing aid devices for all different
environments via Android or iOS Smartphone's. The ALPHA
series gives
InnerScope
the
ability to offer the latest in hearing aid and wireless Bluetooth
technology at 3 different affordable price points and technology
levels.
"The
FDA cleared hearing aid devices paves the way for
InnerScope
to
help the 40 million people in the U.S. and over 466
million people worldwide who suffer from disabling hearing loss",
said Matthew Moore, CEO
of InnerScope
Hearing
Technologies.
"These ALPHA
hearing aid devices have
the performance, power and flexibility to be customized to fit a
variety of different hearing losses, from mild to profound hearing
loss. We are proud to offer our ALPHA hearing aid devices online
Direct-to-Consumer with the latest high quality digital processing
and Bluetooth compatible using smartphone app, at a fraction of the
cost of traditional hearing aid devices offered by Brick-and-Mortar
locations. In addition to the cost savings, there is also hours of
time savings, no more trips back and forth to the hearing
healthcare office to get prescription fitted hearing
device."
"We
made it very easy, simple and affordable to buy a prescription
fitted hearing aid devices online at www.nohasslehearing.com
without
sacrificing quality or service. InnerScope
offers
a hassle-free frictionless
one-click checkout solution which gives customers a choice of 2
simple no-hassle payment and instant financing options
through
our
consumer financing partner Klarna,
allowing
the customers to spread the cost of their purchases over a 6 to
24-month period at 0% annual percent rate depending on transaction
value, giving them flexibility and increased purchasing power. We
are proud to deliver extremely affordable high quality digital and
wireless hearing aid technology to the millions of people who are
currently suffering from the consequences of untreated hearing loss
mainly due to high cost, inconvenience and lack of accessibility of
high quality hearing aid and healthcare products and
services," Mr. Moore
concluded.
About
InnerScope Hearing Technologies
(INND)
InnerScope
Hearing
Technologies (INND) is a technology driven company with highly
scalable B2B and B2C solutions. The Company plans on offering a B2B
SaaS based Patient Management System (PMS) software
program,
designed to improve operations and communication with
patients. INND
also offers a Buying Group experience for audiology practice,
enabling owners to lower product costs and increase their margins.
INND will also compete in the DTC (Direct-to-Consumer) markets with
its own line of "Hearable", and "Wearable" Personal Sound Amplifier
Products (PSAPs) and revolutionary APPs on the iOS and Android
markets.
INND
has plans on opening, operating and expanding a chain of
audiological and retail hearing device clinics. INND's seasoned
team of professionals, with collectively over 200+ years of
experience in the hearing aid industry, including successful
operations in hearing aid manufacturing and retail store
management. Our team has the knowledge, relationships, and the
experience to quickly deploy new products and software to serve
approximately 1.2 billion people around the globe that are
suffering with 25 db
or
greater hearing loss. For
more information, please visit www.innd.com
About FDA Regulation of
Hearing Aid Devices:
CFR - Code of
Federal Regulations Title 21
PART 874 -- EAR, NOSE, AND THROAT DEVICES
Subpart
D--Prosthetic Devices
Sec. 874.3305
Wireless air-conduction hearing aid.
(a) Identification. A
wireless air-conduction hearing aid is a wearable sound-amplifying
device, intended to compensate for impaired hearing that
incorporates wireless technology in its programming or
use.
(b)
Classification: Class II (special
controls)
Hearing aids are
restricted
by regulation
with respect to device labeling
(21 CFR 801.420)
and conditions for sale
(21 CFR
801.421).
Hearing aid mean any wearable instrument
or device designed for, offered for the purpose of, or represented
as aiding persons with or compensating for, impaired hearing. (21
CFR 801-420)
For
more information, please visit
:https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=1608
Sec. 874.3300
Hearing Aid.
(a) Identification. A hearing
aid is wearable sound-amplifying device that is intended to
compensate for impaired hearing. This generic type of device
includes the air-conduction hearing aid and the bone-conduction
hearing aid but excludes the group hearing aid or group auditory
trainer (874.3320), master hearing aid (874.3330), and tinnitus
masker (874.3400).
(b) Classification. (1) Class
I (general controls) for the air-conduction hearing aid. The
air-conduction hearing aid is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to 874.9. For
more information, please visit:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=874.3300
Safe Harbor
This presentation contains
forward-looking statements which relate to future events or
InnerScope
Hearing
Technologies future performance or financial condition. Any
statements that are not statements of historical fact (including
statements containing the words "believes," "should," "plans,"
"anticipates," "expects," "estimates" and similar expressions)
should also be considered to be forward-looking statements. These
forward-looking statements are not guarantees of future
performance, condition or results and involve a number of risks and
uncertainties. Actual results may differ materially from those in
the forward-looking statements as result of a number of factors,
including those described from time to time in InnerScope
Hearing
Technologies filings with the Securities and Exchange
Commission. InnerScope
Hearing
Technologies undertakes no duty to update any forward-looking
statements made herein.
Contact:
Investor
Relations Contact
Andrew
Barwicki
516-662-9461
Andrew@barwicki.com
InnerScope
Hearing
Technologies,
Inc.
Matthew
Moore
Matthew@innd.com
916-218-4100
www.innd.com
www.nohasslehearing.com
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=1608
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=874.3300
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