InnerScope Hearing Technologies Receives its FDA Class I and II Importers Clearance on their ALPHA Brand Hearing Aid Device Products

Roseville, California, UNITED STATES


The Company will offer its own line of FDA-cleared hearing aid devices through its www.nohasslehearing.com eCommerce store

ROSEVILLE, Calif., May 30, 2018 (GLOBE NEWSWIRE) -- via OTC PR WIRE -- (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.comwithout 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 restrictedby 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