- FDA wants a new category of OTC hearing aids for people with mild to moderate hearing losses that generally go without any hearing assistance
- The proposed regulation benefits InnerScope, a direct-to-consumer company selling innovative hearing products, including an FDA-registered Bluetooth app-controlled self-adjusting hearing aids
- InnerScope has made two substantial acquisitions in 45 days, one completed with iHear Medical Inc. and HearingAssist, which expects $150+ million in revenue by 2024 anticipated to close this month.
Historically, hearing aids have been very expensive, bulky, and inexplicably lacking sufficient (if any) insurance coverage. But, finally, times are changing, and the FDA is spearheading a charge towards affordability and accessibility for up to 70 million Americans suffering from impaired hearing. So the timing couldn’t be better for InnerScope Hearing Technologies (OTC: INND) to be innovating in the market, offering its hearing aids and related goods on multiple websites and striking a deal to buy one of the biggest names in the business.
Hearing loss is more damaging than may appear at first blush. It is a serious drag on quality of life, causing people to be withdrawn and embarrassed because they can be viewed as confused or uncooperative simply because they can’t hear well. As it happens, people with hearing loss are more than twice as likely (11% vs. 5%) to suffer from depression as the general population. Sadly, only about 1 in 5 people that would benefit from a hearing aid actually seek help, creating a massive void in healthcare.
In a landmark proposal, the FDA wants to see a new category of over the counter (“OTC”) hearing aids catering to people with mild to moderate hearing loss that generally go without any hearing assistance. Incidentally, the initiative is personal to Health and Human Services Secretary Xavier Becerra, whose own mother was bilked out of money by an unscrupulous hearing aid manufacturer. The FDA has also set its sights on cracking down on those manufacturers of sound amplification devices skirting regulations to prey on consumers.
These regulatory changes, which still must undergo a 90-day comment period before a 60-day implementation deadline, are beneficial to direct-to-consumer specialists like InnerScope, which manufactures, develops, distributes, and sells innovative hearing health-related products, solutions, and treatments, including an FDA-registered Bluetooth app-controlled self-adjusting hearing aids and personal sound amplifiers products.
The California-based company has recently launched its world-class hearing aids, and related products on MyHearIQ.com, FSAstore.com, HSAstore.com, and WellDeservedHealth.com, focusing on affordability by targeting consumers enrolled in flexible spending accounts (“FSA”), health saving accounts (“HAS”), and employers’ health incentive programs. InnerScope has partnered with the online retailer and industry leader in the U.S. tax-free healthcare market. Furthermore, the company’s hearing aids and other portfolio products qualify as eligible for FSA and HSA users and are the only company on the retailers’ websites to offer hearing aids.
InnerScope’s founders and their heritage has been in the retail hearing device business for 70+ years, is amid a growth phase spurred on by an aggressive growth strategy. On October 5, the company announced it completed an acquisition of iHEAR Medical Inc., a pioneer in online direct-to-consumer hearing solutions with a loyal client base.
The merger also widens the InnerScope product bag, including adding iHEARtest(TM), the only FDA-Cleared home hearing screener, advanced FDA-Registered hearing aids, and the TReO(TM) Personal Sound Amplification Product (“PSAP”). iHEAR’s distribution network is diverse, including the likes of CVS Pharmacy, Cardinal Health, AmerisourceBergen, Western States Pharmacy Coalition (WSPC), Good Neighbor Pharmacy, FSA Store, Amazon, Ameritas, and VIA Benefits, to name just a few.
On October 19, InnerScope struck another major deal, inking a Letter of Intent to acquire Hearing Assist II LLC. The LOI is expected to follow a definitive agreement with a targeted closing date of November 15, 2021.
Founded in Virginia Beach 13 years ago, HearingAssist was years ahead of the Eargo “Heck Yeah!” guy as the first DTC hearing aid company to use mass national television marketing to create a recognizable brand as America’s #1 Affordable Hearing Brand (National Television Commercial).
Since its inception, HearingAssist has sold more than 500,000 hearing aids to nearly 400,000 customers via direct-to-consumer or through retail partners. The company sells products via multiple channels, including 757 Walmart stores in five states, and has generated $72+ million in revenue with its national television commercials through July 2021
With the expected OTC Law coming into effect in 2022, HearingAssist brand revenue projections are expected to exceed $150 million annualized by 2024.
For more information, visit the company’s website at www.INND.com and the company’s e-commerce website: www.MyHearIQ.com.
NOTE TO INVESTORS: The latest news and updates relating to INND are available in the company’s newsroom at https://ibn.fm/INND
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