InnerScope Hearing Technologies (OTC: INND) Announces FDA Has Released The Final Rule For OTC Hearing Aids 

Rhea-AI Summary

InnerScope Hearing Technologies announced plans to register its hearing aids in compliance with the FDA's OTC Final Rule, allowing for retail sales without a medical exam. The enactment of the OTC Hearing Aid Law on October 16, 2022, will facilitate consumer access to hearing aids in stores and online, potentially transforming a market currently dominated by expensive clinical fittings. InnerScope aims to leverage its network of retailers, including Walmart, to introduce affordable options priced between $499 to $1,500 per pair, addressing the needs of millions of Americans with undetected hearing loss.

Positive

• Plans to register hearing aids under FDA's OTC Rule, enhancing market access.
• Anticipation of a new revenue stream as consumers gain access to affordable hearing aids.
• Collaboration with major retailers like Walmart and Best Buy boosts distribution potential.

Negative

• None.

InnerScope is Well-Positioned With its Network of Wholesale Retailers and Plans to Register its Hearing Aids in Compliance with FDA's OTC Final Rule for Over-the-Counter Hearing Aids to be Sold in Retail Stores and Pharmacies

ROSEVILLE, Calif., Aug. 16, 2022 (GLOBE NEWSWIRE) -- via InvestorWire – InnerScope Hearing Technologies Inc. (OTC: INND) ("InnerScope"), an emerging and disruptive leader in the Direct-to-Consumer Hearing Technology space and soon-to-be leading the way in the Over-the-Counter ("OTC") Hearing Technology space, is pleased to announce today that the FDA has released the "Final Rule" (FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans | FDA) for creating a new category of Over-the-Counter hearing aids for perceived mild to moderate hearing losses to be sold directly to consumers in retail stores, pharmacies and online without a medical exam or being fitted by a hearing healthcare professional ("OTC Hearing Aid Law"). On or about October 16, 2022, sixty days after the Final Rule is published in the Federal Register (see Final Rule: 2022-17230.pdf (federalregister.gov), the OTC Hearing Aid Law will be enacted, allowing consumers to purchase OTC Hearing Aids right off the shelf directly from multiple retailers, including Big Box retailers and pharmacy chains.

Official Biden Administration Response: https://twitter.com/VP/status/1559529233470439427/video/1

Since Congress in 2017 passed a bipartisan proposal, signed into law by President Donald Trump, to allow hearing aids to be sold over the counter, InnerScope has been diligently working to put into place a network of multiple large retailers, including Walmart, Best Buy, Rite Aid ("Network of Wholesale Retailers") with wholesale vendor agreements to sell its assortment of hearing aid products and related hearing aid supplies ahead of the OTC Hearing Aid Law being enacted. InnerScope plans to register its hearing aid products, which include its HearingAssist and iHear branded hearing aid products, as OTC Hearing Aids in compliance with the FDA's Final Rule ("InnerScope's OTC Hearing Aid Products") and will be offered to its current and future Network of Wholesale Retailers to be sold in-store right off the shelf and online through each retailers' website.

98% of all hearing aids are sold and fitted in a traditional brick-and-mortar clinical environment by a hearing healthcare professional at an average cost of $5,000 a pair (the current "Traditional Hearing Aid Delivery Model"). However, approximately 48 million Americans report having trouble hearing; despite the high prevalence and public health impact of hearing loss, only about 14% of people who could benefit from hearing aids use them. The low market penetration is mainly due to the high cost of the Traditional Hearing Aid Delivery Model and certain state and federal regulatory barriers. The OTC Hearing Aid Law lowers those barriers to allow greater access to affordable hearing aids. The OTC Hearing Aids are expected to cost between $500 to $1,500 for a pair of hearing aids.

InnerScope's OTC Hearing Aid Products are expected to be priced between $499 to $1,500 a pair. InnerScope believes that since most people have not had their hearing tested since grade school, tens of millions more Americans have undetected mild to moderate hearing loss. As a result, InnerScope, with its Network of Wholesale Retailers, its unique selling proposition with its in-store 3 to 5-minute Free Self-administered Automated Point of Sale Hearing Screening Kiosk ("Hearing Kiosks") and online hearing screening software for the retailers' customers, believes it is well-positioned and poised to take be the leader in the new emerging OTC hearing aid market.

"We have been waiting over five years for this day to come," said Matthew Moore, president and CEO of InnerScope Hearing Technologies.  "The true winners of the OTC Hearing Aid Law will be the consumers that have had to struggle and live with their hearing difficulties due to the high-cost hearing aids with the current Traditional Hearing Aid Delivery Model. First, I would like to thank Senator Elizabeth Warren (D-Mass) and Senator Chuck Grassley (R-Iowa) for their hard work and dedication in introducing this bipartisan Over-The-Counter Hearing Aid Act bill in 2016 and President Joe Biden for issuing an executive order to push the OTC Hearing Aid Law to be enacted finally. Second, the OTC Hearing Aid Law will open a new emerging market for hearing aids sales, potentially in the tens of billions of dollars. InnerScope, with its Network of Wholesale Retailers, is ready when the OTC Hearing Aid Law is enacted to deliver its affordable OTC hearing aids to tens of millions of Americans."

About InnerScope Hearing Technologies, Inc. (OTC PINK: $INND):

InnerScope Hearing Technologies Inc. is a leading Direct-to-Consumer (DTC) manufacturer and distributor of FDA-registered hearing aids, hearing assistive devices, hearing health-related products, and Personal Sound Amplifier Products (PSAPs) ("Hearing Products") dedicated to addressing the global demand for affordable hearing solutions. InnerScope's Hearing Products and its business model break through the persistent barriers that prevent access to effective hearing solutions.

InnerScope's recent acquisition of iHear Medical Inc., a DTC cloud-based hearing solution provider, gives the Company access to over 40 patents and an FDA-registered manufacturing and R&D facility. In addition, InnerScope has acquired HearingAssist, an established leader in the direct-to-consumer hearing aid market with a customer base of over 400,000. These acquisitions, combined with a partnership with Atlazo Inc., a semiconductor innovator for next-generation AI smart devices, will allow InnerScope to better position itself in the direct-to-consumer hearing solutions market by selling advanced hearing products through Walmart and other major retailers.

InnerScope's full line of Hearing Products is currently available through these multiple retail/wholesale channels: Walmart Vision Centers, Walmart.com, Walmart Canada, RiteAid.com, BestBuy.com, Amazon.com, Fingerhut.com, Giant Eagle, Hy-Vee, Hartig Drug, Food City, and Cardinal Health dba RGH Enterprises Inc., which provides InnerScope products to FSAStore.com, HSAStore.com, & WellDeservedHealth.com. In-store and online Hearing Products are launching soon with more major retailers and pharmacy chains.

For information related to InnerScope Hearing Technologies' latest hearing aids and related hearing products, please visit:
http://iheardirect.com

http://hearingassist.com

For the most up-to-date information about InnerScope Hearing Technologies (OTC: $INND), please visit and follow our official Twitter account @inndstock page:
https://twitter.com/inndstock

InnerScope Hyperlinks:
HearingAssist
hearing assist - Walmart.com
Acquisition of iHear Medical Inc.
Acquisition of HearingAssist

Safe Harbor
This news release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended intended to be covered by the "safe harbor" created by those sections. Any statements that are not historical facts contained in this press release are also "forward-looking statements" as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA). Such statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning. Such forward-looking statements are based on current expectations, involve known and unknown risks, a reliance on third parties for information, transactions or orders that may be cancelled, and other factors that may cause our actual results, performance or achievements, or developments in our industry, to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from anticipated results include risks and uncertainties related to the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing or maintain contractual relationships with vendors and customers, competition, general economic conditions and other factors that are detailed in our periodic reports filed with the Securities and Exchange Commission ("SEC"). We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA, Securities Act and Securities Exchange Act.

Contact:
InnerScope Hearing Technologies, Inc. OTC: #INND
Investor Relations        
ir@innd.com
833-788-0506
www.innd.com

Investor Relations Agency Contact:
Skyline Corporate Communications Group, LLC 
Lisa Gray, Senior Account Manager
One Rockefeller Plaza, 11th Floor 
New York, NY 10020 
Office: (646) 893-5835 
Email: lisa@skylineccg.com

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FAQ

What is the OTC Hearing Aid Law and its significance for INND?

The OTC Hearing Aid Law allows consumers to purchase hearing aids over the counter without a medical exam, enabling easier access to affordable solutions, which is significant for INND's growth potential.

When will the OTC Hearing Aid Law be enacted?

The OTC Hearing Aid Law is set to be enacted on October 16, 2022, following the FDA's Final Rule publication.

How does InnerScope plan to distribute its hearing aids?

InnerScope plans to distribute its hearing aids through a network of wholesale retailers, including Walmart, Best Buy, and Rite Aid.

What is the expected price range for InnerScope's OTC hearing aids?

InnerScope's OTC hearing aids are expected to be priced between $499 and $1,500 per pair.

How many Americans are affected by hearing loss?

Approximately 48 million Americans report experiencing trouble hearing, highlighting a substantial market for InnerScope's products.