InnerScope has completed the FDA Medical Device Registration for Class II Hearing Aid, Air Conduction with Wireless Technology, and is preparing for theLaunch ofits Latest in Direct-to-Consumer Hearing Aid Technology with its Smartphone App-ControlledSelf-Fitting– Self-AdjustingRechargeable Hearing Aids
ROSEVILLE, CA, March 3, 2021 — — InnerScope Hearing Technologies Inc. (OTC Pink: INND) (“InnerScope”) announced today it has completed and updated the FDA Medical Device Registration for Class II Hearing Aid, Air Conduction with Wireless Technology (“FDA Medical Device Registration”). The completion of the FDA Medical Device Registration (Registration Establishment Number 3014545266) for InnerScope’s Nexus HD, HearIQ ITC, HearIQ4, and the HearIQ20, its newest family of rechargeable hearing aid devices, and as well as its Alpha Series of hearing aid devices. The FDA Medical Device Registration is one of the last steps needed for InnerScope to launch its latest in Direct-to-Consumer Hearing Aid Technology with its Smartphone App-Controlled Self-Fitting – Self-Adjusting Rechargeable Hearing Aids with built-in Professional Remote Programming & Support Service (“Self-Fitting Hearing Aids”).
InnerScope plans on launching its Self-Fitting Hearing Aids on multiple online platforms with the upcoming announcements of several retailers and on its own newly revamp NoHassleHearing.com (expected to be finished by the end of the month). In preparation for the launch, InnerScope has ramped up its inventory of its Self-Fitting Hearing Aids and Hearing Products for the anticipation of generating over five hundred thousand dollars ($500,000) to InnerScope of sales revenue for the launch.
Direct-to-Consumer Hearing Aid Devices (“DTC”) vs. Over the Counter Hearing Aid Devices (“OTC”)
Approximately 48 million Americans experiencing age-related hearing loss don’t have direct access to affordable hearing aid technology, mainly due to excessive regulations established by some states requiring customers to purchase hearing aids exclusively from state-licensed hearing aid providers. This lack of access to hearing aids has led to the Over the Counter Hearing Aid Act becoming law, which establishes a new category of OTC hearing aids. The OTC hearing aid legislation will make certain types of hearing aids available over the counter to Americans with mild to moderate hearing impairment. Currently, OTC hearing aids do not exist until the effective date, after the FDA publishes its final regulation (expected early 2021).
However, DTC hearing aid devices sold online are legal. Due to a 2006 Federal Court Decision of state laws requiring state license dispensers to fit hearing aids exclusively, the Federal 8th Circuit Court of Appeals struck down. The court decision determined under federal regulations, an adult patient that wishes to purchase a hearing aid, must either undergo an auditory evaluation or executed a signed waiver prior to being allowed to purchase a hearing aid (21 C.F.R. §801(a)). Therefore, under federal law, an auditory examination becomes optional prior to purchasing hearing(s). In December 2016, further strengthens the court decision with the FDA publishing a guidance document, stating that the agency will not enforce the requirement for a medical evaluation or waiver under 21 C.F.R §801.421.
The court decision paved the way for DTC hearing aid devices to be legally sold online. Although FDA-Registered DTC hearing aid devices have been sold online for a while, they were always at a much higher price point than unregulated personal sound product amplifiers (“PSAPs”) sold online. Moreover, until recent advances in smartphone technology, PSAPs and hearing aids sold online (“online hearing products”) had no capabilities to be personalized to an individual or their hearing needs. Thus, online hearing products were just amplifiers with preset programs and volume controls.
InnerScope believes its DTC Self-Fitting Hearing Aids have the same capabilities to deliver a personalized hearing experience unique to an individual hearing needs, just as hearing aids are sold and fit by licensed hearing aid providers. The difference is InnerScope can provide this personalized hearing experience at 60% to 85% lower cost versus hearing aids sold and fit by licensed hearing aid providers.
Since 2018, InnerScope’s FDA Registered Alpha Series hearing aid devices have been sold online through its NoHassleHearing.com eCommerce sales platform and sold to Walmart customers through Walmart.com as a direct ship wholesale vendor. When a DTC hearing aid device is FDA-Registered, it carries the same FDA regulations and classifications as hearing aid devices sold and fit by licensed hearing aid providers in brick-and-mortar professional settings. Meaning, there are no restrictions to certain types of hearing aids or any limitations to the amount or degree of hearing impairment, unlike the proposed OTC hearing aid regulations that will allow mild to moderate degree of hearing impairment.
Matthew Moore, CEO of InnerScope Hearing Technologies, commented, “completing FDA Medical Device Registrationgives InnerScope a clear path for launching its Self-Fitting Hearing Aids.InnerScope’s Self-Fitting Hearing Aids will deliver 21st Century hearing aid technology right to everyone’sfingertipsjust by using their smartphone. Also, by cutting out the middleman (the hearing aid professional/provider), InnerScope can also deliver affordability to the customer without sacrificing hearing quality or satisfaction. InnerScope’s Self-Fitting Hearing Aids empowers the user to take full control of their hearing health needs. Once the FDA publishes its final regulationfor the Over the Counter Hearing Aid Act, InnerScope will submit its Self-Fitting Hearing Aidsfor thenew FDA-OTC Medical Device Registration.We believe the solid foundation we built over the last three years has InnerScopein a prime position as a leader in the emerging DTC/OTChearing aid market. WithInnerScope’scurrent and upcoming retail distribution/vendor sales channels will produce consistent and ongoing revenue growth.”
About InnerScope Hearing Technologies (OTC Pink: INND)
InnerScope Hearing Technologies as a manufacturer, distributor, and retailer of FDA-Registered Direct-to-Consumer (“DTC”) Self-Fitting–Self-Adjusting Hearing Aids, Self-Fitting–Self-Adjusting Personal Sound Amplifiers Products, Doctor-Formulated Dietary Hearing & Tinnitus Supplements, and Assorted Ear & Hearing Health-Related Products (collectively “Hearing Products”) its mission is to improve the quality of life of the 70 million people in North America who suffer from hearing impairment and/or hearing-related issues. The management team of InnerScope is applying decades of industry experience and believes it is well-positioned to directly benefit from the Over the Counter Hearing Aid Act (expected to be enacted in early 2021). InnerScope with its Affordable Self-Fitting – Self-Adjusting Hearing Technology, combined with its innovative point of sale Hearing Screening Kiosks designed for consumers with mild-to-moderate hearing loss to purchase over-the-counter hearing aids without being seen by a hearing care professional. For more information, please visit www.innd.com for more info.
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InnerScope Hearing Technologies, Inc.
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