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Manufacturers Group Asks FDA to Crack Down on Crypto-Hearing Aids

By David H. Kirkwood, Hearing Health Matters 4/2/2012
Thanks to Bob MacPherson
The Hearing Industries Association (HIA) has called on the Food and Drug Administration (FDA) to start enforcing its regulations governing hearing aids, even when the devices are ostensibly “personal sound amplification devices” or PSAPs.
In an April 19 letter to Steven Silverman, director of the Office of Compliance at FDA’s Center for Devices and Radiological Health, Jeffrey Gibbs, HIA’s counsel, cited a number of products that are being sold online without FDA’s clearance even though, he said, they are clearly intended to be used as hearing aids, and not as PSAPs, which are not approved for use by people with hearing loss.  
Gibbs told the FDA official, “We request that you take enforcement action against the companies making hearing aid claims for their PSAPs.” He added, “Given the widespread nature of these violations, and the abuse of the [FDA] guidance document ‘Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products,’ we request that you revise the PSAP Guidance to both tighten and reinforce the limits of the claims that may be made by PSAP manufacturers.”
Gibbs added, “The failure to act will result in the erosion of the consumer protections that the FDA has established for hearing-impaired individuals, simply by allowing companies to market hearing aids as ‘PSAPs.’”
In 2009, the FDA published a document spelling out for consumers the distinctions between hearing aids, which are medical devices that cannot be sold without the agency’s approval, and PSAPs, which are not medical devices subject to the hearing aid regulations.
In that document, Eric Mann, MD, PhD, deputy director of FDA’s Division of Ophthalmic, Neurological, and Ear, Nose, and Throat Devices, explained, “Hearing aids and personal sound amplification products (PSAPS) can both improve our ability to hear sound. They are both wearable, and some of their technology and function is similar.”
However, he continued, only hearing aids are i ntended to compensate for impaired hearing. PSAPs are intended for non-hearing-impaired consumers who wish to amplify sounds in the environment for a number of reasons, such as for recreational activities.
The FDA advisory added, “Choosing a PSAP as a substitute for a hearing aid can lead to more damage to your hearing. It can cause a delay in diagnosis of a potentially treatable condition. And that delay can allow the condition to get worse and lead to other complications.”
HIA insists that FDA is ignoring the clear differences that its own document spelled out between hearing aids and PSAPs. Gibbs’s letter points to four companies that are selling products that are clearly targeted at people with hearing loss.
For example, he said, the company marketing Neutronic Ear®, writes that “Hearing aids haven’t changed much” since the introduction of wearable hearing aids. But, it says, “Now there’s an alternative… NeurotronicEar.
Comparing its product with standard hearing aids, NeurotronicEar says, “Until now, everyone was required to see the doctor, have hearing tests… The devices can cost up to $5000 each!… The high cost and inconvenience drove an innovative scientist to develop the Neutronic Ear Personal Sound Amplifier.”
Gibbs contended, “These statements all demonstrate that Neutronic Ear is promoting its product for hearing loss, comparing the product to hearing aids, and implying that the Neutronic Ear and hearing aids may be used interchangeably and serve the same purpose.”
Similarly, Gibbs noted, Audivox Accessories claims that its PSAPs “provide a highly affordable solution for consumers with mild-to-moderate hearing loss.” And Stealth Secret Sound Amplification describes its Focus Ear Personal Sound Amplifier as “like reading glasses for the ears.”
General Hearing Instruments, which still manufactures hearing aids that are dispensed through professionals, also offers two models of “Ready Wear Hearing Aids,” Simply Soft and Simplicity, that are sold directly to consumers at the Walmart and Sam’s Club retail websites.
HIA’s attorney wrote: “The manufacturers and claims presented here are representative of the hearing aid claims being made by various PSAP manufacturers. “It is clear from these statements that these devices are being sold as hearing aids, not PSAPs. Selling these products over the counter for use by an individual with hearing impairment, without any participation from a healthcare practitioner, raises the same safety concerns FDA has previously expressed about sale of hearing devices over the counter.”
Gibbs added, “In light of these safety concerns and the flagrant disregard for the limitations on claims for PSAPs by multiple companies, we ask FDA to contact each of the companies mentioned in this letter, along with any other PSAP manufacturers of which FDA is aware, informing them that they may not continue to market hearing aids in the guise of PSAPs.”
He concluded, “Given the importance of these issues, HIA requests a meeting to discuss this with you further.”