Is $INND even in compliance with current U.S. Food and Drug Administration?
I was reading the FDA Reauthorization Act of 2017 and noticed some things that frankly confuses me.
First question -- Are $INND products Hearing Aid Devices or Personal Sound Amplification Products (PSAPs) under the Act?
The recent changes to the Act, that is so often touted by the company, creates a new device category, per below which is taken directly from the FDA's notice.
"The agency proposes a rule to establish a new category of over-the-counter (OTC) hearing aids. When finalized, the rule would allow hearing aids within this category to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist."
What products are $INND selling right now?
We all know that the Moore family supposedly lost a their licenses per their settlement a few years back, so who's their audiologist currently? What responsibility does the company have to its clients?
Next question -- It has been alleged that the company, until its acquisition of hearingassist, was buying, re-packaging and selling cheap Alibaba product. Has anyone checked to see that these products meet our FDA standards? If not, is there liability there for prior sales that should be brought to the attention of the FDA?
Per the proposal:
"To ensure patient safety, the proposed rule also addresses a maximum output (volume) limit for OTC hearing aids that would prevent injuries from overamplification of sound. In addition, the proposed rule includes certain device performance and design requirements, such as distortion control limits, self-generated noise limits, latency limits (how quickly an OTC hearing aid processes, amplifies and relays a sound), the range of frequencies that the device can reproduce and how uniformly the OTC hearing aid amplifies different frequencies over its bandwidth, as well as a requirement to limit the insertion depth of the device."
The FDA also issued an updated draft guidance, Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs). Do we know if $INND is compliant with any of these requirements?
