Devices

Praise, Suggestions for Hearing Aid Rule

The FDA proposed rule on establishing over-the-counter (OTC) hearing aids to implement provisions of the FDA Reauthorization Act of 2017 has drawn praise and recommendations for change from several stakeholders. The Federal Trade Commission commented that it supports the proposed rule “given the benefits to competition and healthcare consumers that the rule would likely promote…. We believe that the proposed rule would, if adopted, serve to enhance competition and innovation among hearing aid retailers and manufacturers.”

In its response, the National Association of Chain Drug Stores says it supports the proposed rule and urges FDA to act swiftly to finalize the rule so the public can realize its benefits as soon as possible. The association suggests FDA further consider several issues it specifies.

Several concerns were expressed by the American Academy of Audiology. It said the FDA proposal falls “far short of honoring the key principles of the authorizing legislation and ensuring public health protection in the regulations.” It provided specific comments to address major areas of the proposed regulations that it says don’t satisfy minimal expectations relative to patient safety, efficacy, and consumer protection.

In its letter, the National Association of Attorneys General urges FDA to remember and honor the role of states in regulating hearing aids. It asks the agency to consider three proposals to clarify the impact of the proposed rule on state regulations related to all hearing aids, including over-the-counter hearing aids.

Finally, the Consumer Healthcare Products Association says that while it supports FDA creation of a regulatory category of OTC hearing aids, there are important areas of the proposed rule that require clarification. It cites (1) the scope of legacy and wireless OTC hearing aids that could meet the requirement to include tools, tests, and software but would not be considered self-fitting; (2) how OTC hearing aids will obtain 510(k) exempt status after finalization of the proposed rule; and (3) application of the package labeling requirements to OTC hearing aids in small packaging with limited available labeling space on the package.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome