Retail options already available following signing of OTC hearing aid legislation
NEW YORK — It’s done. A hearing aid category specific to the over-the-counter arena was signed into law in August; all that remains to be created is the regulatory framework. Even though that may take time, there are two reasons to be optimistic that a hearing aid category will be in pharmacies sooner than later.
First, the Center for Devices and Radiological Health was calling for an OTC hearing aid category long before legislators started including that language in their bills. “We look forward to working with the clinical community, the patient community, the industry and others,” said Jeffrey Shuren, director of the center, during a Congressional hearing earlier this year. “The public health challenges today are so great, and the status quo today is not adequately addressing the needs of the majority of patients with hearing loss, that an over-the-counter hearing aid category could be one way of trying to address those concerns.”
Second, opportunities to build an OTC hearing aid set today exists, including products targeting mild-to-moderate hearing loss that have been vetted — and approved — by the FDA. In fact, coming out of NACDS TSE, several early adopters already drafted plans to incorporate those hearing aids into their stores as early as January 2018.
“The iHear test, for example, is FDA-cleared for retail sale,” Varun Bhardwaj, CIO and general counsel of iHear Medical, told Drug Store News. According to the company, it’s the only take-home test currently approved by the FDA. “With regard to the hearing aid, we’re prepared to [ship] a kiosk, display unit and demos into the stores, and, depending upon the preferences of the partner, we can fulfill any orders directly to the consumer.”
That makes the most pressing question one of adjacency — will consumers more likely search for a hearing aid solution near ear care or diagnostics? “Hearing aid products require disposable batteries and disposable ear tips,” said Robert Barone, head of marketing and clinical development at iHear Medical. Earwax cleaning solutions, health monitoring devices, dietary supplements and medical supplies all are synergistic categories, he said, as people with diabetes are twice as likely to have hearing loss. There also is a strong correlation between hearing loss and heart disease.
The fastest-growing hearing-impaired segment skews much younger, ages 18-to-35 years old, thanks to the ubiquity of ear buds and headphones, and a robust gaming community. For that younger group, such technologically sophisticated sound amplification devices as Nuheara’s recently released IQbuds may be an ideal entry point into the category. “We’re in the process of creating a brand recognized as an intelligent hearing device,” said David Cannington, EVP of sales and marketing at Nuheara. IQbuds work wirelessly with smartphones and other devices, and allow the user to selectively tune in or tune out the world around them. “This is just the beginning of the product development journey.”
However, at the outset at least, there may be a price perception hurdle to overcome. While the average cost per ear of a prescription hearing aid runs north of $2,400, the average cost per ear of an OTC hearing aid, so far at least, is coming in at around $300. According to a survey conducted by Healthy Hearing in the spring, fewer than 20% of consumers would be willing to spend more than $100 on an OTC hearing aid device.
