InnerScope Hearing Technologies announced 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, according to the company’s press release.  This gives the Company the legal right to import, market, and sell the ALPHA-branded label hearing aid devices in the United States. The FDA Class I and Class II clearances are part of the Company’s overall strategic plan to continue to expand its footprint within the US hearing aid market by creating strategic partnerships and exclusive supply agreements with hearing aid suppliers and manufacturers around the world to bring unique and affordable hearing technology via direct to consumers for the US and global markets.

The ALPHA hearing aid series are receiver-in-canals (RICs) with what the company says is a “discreet and comfortable compact design” with Bluetooth Low Energy (BLE) wireless technology (for direct connection to external Bluetooth-enabled devices) with a user app for added control and personalizing the hearing aid devices for all different environments via Android or iOS smartphones. The ALPHA series gives InnerScope the ability to offer the latest in hearing aid and wireless Bluetooth technology at three different price points and technology levels.

“The FDA-cleared hearing aid devices pave the way for InnerScope to help the 40 million people in the US 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 are also hours of time savings; no more trips back and forth to the hearing healthcare office to get prescription-fitted hearing devices.

“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 two 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,” Moore concluded.

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

Source: InnerScope