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OTC Hearing Aid Consensus Statement Published by AAA, ADA, IHS, and ASHA

Aug 14, 2018 | In the Ear, Over the Counter, Personal Sound Amplification | 8 |

The unprecedented consensus statement from four national hearing care professional organizations recommends the new FDA classification be called “Self-fit OTC hearing devices.” The paper recommends the new class be intended for mild-to-moderate hearing losses of 26-55 dB HL (26 max HFA-FOG/110 dB max output), offer input compression and volume controls, contain clear and easy-to-understand labeling both on the inside and outside of the packaging, and require at last one 510(k) filing for initial FDA approval to ensure the basic safety and efficacy of the device.

How Will OTC Deregulation Affect the Six Major Global Hearing Aid Companies?

Aug 7, 2018 | Over the Counter, Regulation | 0 |

With the deadline for the FDA to publish guidelines related to over-the-counter (OTC) hearing aids looming—the government agency has until 2021, but some say it may be as early as the middle of 2019—many are wondering how that will affect the six major global hearing aid companies.

FDA Issues Letter to “OTC Hearing Aid” Manufacturers

Jul 25, 2018 | Evaluation, Industry News, Marketing, Over the Counter, Personal Sound Amplification, Regulation | 21 |

A letter by the FDA’s William Maisel cautions that hearing devices cannot use “OTC hearing aids” in their marketing since the FDA definition of this hearing aid class—which would probably include severity of loss and other important safety, quality, and labeling requirements—has not yet been established.

NAL, CAEPs, OTC Hearing Aids, and More: An Interview with Brent Edwards, PhD

Jun 27, 2018 | Hearing Aids, People, Research | 1 |

Brent Edwards, PhD, who has recently been appointed director of the National Acoustic Laboratories (NAL) research center in Sydney, Australia, is interviewed by Douglas Beck, AuD, in this edition of “HR’s“ Inside the Research. Topics include research at NAL, the NAL’s cortical auditory evoked potential (CAEP) system known as HEARLab, over-the-counter hearing aids, and more.

iHEAR Medical Announces OTC Product Launch in Stores; Appoints John Luna CEO

May 2, 2018 | Over the Counter, People, Personal Sound Amplification, TeleHealth | 2 |

iHEAR will launch the TReO, what the company says is the “first prescription-quality hearing amplifier for OTC markets,” and the iHearTest kit, a FDA-cleared home hearing screener, in 500 drugstores in June 2018.

Simplifying OTC Hearing Devices

Dec 26, 2017 | Continuing Education | 3 |

I predict that a number of problems will need to be solved so that a consumer can pick up an over-the-counter hearing assistance product and have it work as well as a ballpoint pen does for most of us.

Open Letter to OTC Hearing Device Regulators

Oct 31, 2017 | Continuing Education | 2 |

Now that the political hay has been harvested, the real business of affordable and accessible hearing care is on the table and at your mercy.

ADA’s 40th Convention Prepares Members for Disruption and OTC Devices

Oct 4, 2017 | Financial Services, Medicare & Insurance | 3 |

The center of conversation at this year’s ADA Convention was what impact OTC hearing devices would have on the market, their pros and cons, and how best to prepare a practice for changes in the wake of the OTC Hearing Aid Act of 2017.

Staff Standpoint: OTC Debate Moves on to FDA, FTC…and States?

Sep 25, 2017 | Over the Counter, Personal Sound Amplification | 0 |

The debate now moves from “if” an OTC class of hearing devices should exist to “what” that OTC class will look like.

Organizations Release Statements Reacting to OTC Hearing Aid Act Law

Aug 24, 2017 | Organizations, Over the Counter, Regulation | 0 |

Following the announcement of the passage of the legislation into law, several organizations released statements supporting the bill.

President Trump Signs OTC Hearing Aid Legislation into Law

Aug 19, 2017 | Legislation | 81 |

On Friday, August 18, President Donald Trump signed into law today the Food and Drug Administration Reauthorization Act of 2017, legislation that includes the Over the Counter Hearing Aid Act designed to provide greater public accessibility and affordability with over-the-counter (OTC) hearing aids. FDA will now be charged with creating and regulating a new class of OTC hearing aids.

HHTM Releases Results of ‘Audiologist OTC Hearing Aid Survey’

Aug 16, 2017 | Surveys & Statistics | 0 |

The online survey was conducted between August 1 and August 8, 2017, reportedly for the purpose of exploring the views of audiologists on the subject of over-the-counter (OTC) hearing aids. A total of 566 US-based audiologists completed the survey.

William Demant May Enter OTC Hearing Aid Market if US Demand Increases, Says ‘Reuters’ Article

Aug 14, 2017 | Over the Counter, Regulation | 0 |

William Demant—parent company of Oticon, Sonic, and Bernafon—said it would start producing over-the-counter hearing aids if customer demand increases after passage of the Over-the-Counter Hearing Aid Act.

US Senate Passes OTC Hearing Aid Act as Part of FDA Reauthorization Act of 2017

Aug 4, 2017 | Over the Counter, Regulation | 3 |

The US Senate passed the FDA Reauthorization Act of 2017—which includes the Over-the-Counter (OTC) Hearing Aid Act of 2017—by a vote of 94-1, on August 3.

Letters: Larry Humes Responds to “A Perspective on the Indiana University OTC Outcome Study”

Jul 18, 2017 | Hearing Aids, Over the Counter, Practice Management, Research | 0 |

Larry Humes, PhD, responds to the July 2017 Hearing Review article by John Tecca, which addressed Dr Humes recent article about OTC hearing aids in the American Journal of Audiology and a summary article in the May 2017 Hearing Review.

Search Results for: otc

OTC Hearing Aid Consensus Statement Published by AAA, ADA, IHS, and ASHA

How Will OTC Deregulation Affect the Six Major Global Hearing Aid Companies?

FDA Issues Letter to “OTC Hearing Aid” Manufacturers

NAL, CAEPs, OTC Hearing Aids, and More: An Interview with Brent Edwards, PhD

iHEAR Medical Announces OTC Product Launch in Stores; Appoints John Luna CEO

Simplifying OTC Hearing Devices

Open Letter to OTC Hearing Device Regulators

ADA’s 40th Convention Prepares Members for Disruption and OTC Devices

Staff Standpoint: OTC Debate Moves on to FDA, FTC…and States?

Organizations Release Statements Reacting to OTC Hearing Aid Act Law

President Trump Signs OTC Hearing Aid Legislation into Law

HHTM Releases Results of ‘Audiologist OTC Hearing Aid Survey’

William Demant May Enter OTC Hearing Aid Market if US Demand Increases, Says ‘Reuters’ Article

US Senate Passes OTC Hearing Aid Act as Part of FDA Reauthorization Act of 2017

Letters: Larry Humes Responds to “A Perspective on the Indiana University OTC Outcome Study”

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