Search Results for: otc

FDA Proposed Rules for OTC Hearing Aids Extend Beyond OTC

FDA Proposed Rules for OTC Hearing Aids Extend Beyond OTC

Oct 20, 2021 | , | 1 |

The 114-page rules document published today in the Federal Register covers most aspects related to OTC hearing aid manufacturing, electroacoustic requirements, packaging and labeling, returns, and conditions for sale. In an effort to promote more consistency in the regulations and enforcement of hearing aid manufacturing and distribution, the FDA is also proposing several important changes that could affect the industry and state-wide hearing aid dispensing.

Read More
FDA Issues Proposed OTC Hearing Aid Rules

FDA Issues Proposed OTC Hearing Aid Rules

Oct 19, 2021 | , | 2 |

To ensure patient safety, the proposed rule addresses maximum output limits and includes certain device performance and design requirements, such as distortion control limits, self-generated noise limits, latency limits, frequency bandwidth, as well as a requirement to limit the insertion depth of the device. The proposed rule also includes labeling requirements for OTC hearing aids. As hoped, the FDA also issued an updated draft guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).”

Read More
‘NBC News’ Article Discusses OTC Hearing Aids

‘NBC News’ Article Discusses OTC Hearing Aids

Aug 26, 2021 | | 0 |

A recent article appearing on the “NBC News” website by Phil Galewitz with “Kaiser Health News,” discusses the expansion of over-the-counter hearing devices currently on the market for people with mild-to-moderate hearing loss, in the absence of FDA regulations governing the 2017 “Over-the-Counter Hearing Aid Law.”

Read More
Emphasizing Patient Care in the OTC Era

Emphasizing Patient Care in the OTC Era

Feb 5, 2021 | | 0 |

How are audiologists preparing for a dispensing landscape that includes OTC hearing aids? Practice owner Stacy O’Brien, AuD, says she consistently emphasizes a full scope of audiology services, best practices, and patient options for affordability and better access to care.

Read More
PSAPs, OTC and Self-fitting Hearing Aids, ACHIEVE, and More: An Interview with Nicholas Reed, PhD

PSAPs, OTC and Self-fitting Hearing Aids, ACHIEVE, and More: An Interview with Nicholas Reed, PhD

Oct 27, 2020 | , , | 0 |

Nicholas Reed, PhD, and his colleagues at Johns Hopkins have been involved in some extremely exciting research on personal sound amplification products (PSAPs) and over-the-counter (OTC) devices, as well as cognition and hearing loss. Douglas Beck, AuD, interviews Dr Reed about these topics, as well as the group’s recent work on the ACHIEVE study.

Read More

✖