Search Results for: otc

Scientifically Rigorous Study Shows Older Adults Benefit from Hearing Aids; Support for OTC Devices

Scientifically Rigorous Study Shows Older Adults Benefit from Hearing Aids; Support for OTC Devices

Mar 2, 2017 | | 7 |

The first-ever placebo-controlled, double-blind, randomized clinical trial of hearing aid outcomes shows that older adults benefit from hearing aid use, including over-the-counter (OTC) devices. There were no significant differences in outcome between the OTC and audiology best-practice service-delivery approaches for 5 of the 6 outcome measures, but the OTC group fared somewhat worse when it came to satisfaction with their hearing aids. Fewer OTC participants were also likely to purchase their hearing aids after the trial (55% for the OTC group vs 81% for the best practices group, with 36% for the placebo group).

Read More
HIA Recommends OTC Hearing Devices Be Restricted to Mild Losses; Retain Consumer Safety and Efficacy Assurances

HIA Recommends OTC Hearing Devices Be Restricted to Mild Losses; Retain Consumer Safety and Efficacy Assurances

Feb 6, 2017 | , | 0 |

The Hearing Industries Association has recommended that, if the FDA creates a new over-the-counter (OTC) category for hearing devices, these products be confined to mild hearing losses and comply with the same safety and efficacy standards required for air-conduction hearing aids. Further, if the OTC category is established, HIA recommends that FDA review and finalize its guidance for PSAPs so these devices cannot be marketed to address hearing loss.

Read More
NASEM Committee Recommends New OTC Hearing Aid Class, End to Waiver System, and Unbundling of Hearing Aid Prices

NASEM Committee Recommends New OTC Hearing Aid Class, End to Waiver System, and Unbundling of Hearing Aid Prices

Jun 3, 2016 | , , , , , , , | 6 |

Among a dozen recommendations, the Committee on Accessible and Affordable Hearing Health Care for Adults would like to see the FDA establish an over-the-counter class of hearing devices, an end to the “waiver system,” hearing aids that have open programming, and portability of consumers’ audiograms and hearing aid programming information.

Read More
FDA Approves First OTC Hearing Test

FDA Approves First OTC Hearing Test

Jan 4, 2016 | , , , | 3 |

iHear Medical announced that it received FDA clearance for the iHearTest, the first hearing test approved for over-the-counter (OTC) sales. The iHearTest is intended to profile hearing ability based on WHO guidelines, targeting adults who suspect they have hearing loss, or those reluctant to seek professional evaluation for a basic hearing assessment.

Read More
PCAST Recommends Creation of “Basic” OTC Hearing Aid Category; Easing of PSAP Regulations

PCAST Recommends Creation of “Basic” OTC Hearing Aid Category; Easing of PSAP Regulations

Oct 23, 2015 | , | 5 |

The President’s Council of Advisors on Science and Technology (PCAST) held an open teleconference on October 23, 2015 to discuss its report, “Aging America & Hearing Loss: Imperative of Improved Hearing Technologies.” Among the PCAST’s recommendations are a distinct FDA category for “basic” OTC hearing aids without the requirement for consultation with a credentialed dispenser, and the FDA’s withdrawal of its draft guidance document regarding personal sound amplification devices (PSAPs), referring instead to this new category as “devices for discretionary consumer use.” The Hearing Industries Assn (HIA) strongly disagrees with the PCAST and says it will be responding to the numerous errors in the report.

Read More
Turning It Down a Notch

Turning It Down a Notch

Mar 14, 2008 | | 0 |

The Baby Boomer generation thought they would hear the music forever, however, many are now having trouble hearing it at all. This problem isn’t just one for older Americans. According to studies conducted in 1999 by the US Food and Drug Adm

Read More

✖