Tag: PSAPs

All

Latest

FDA Issues Proposed OTC Hearing Aid Rules

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 As hoped, the FDA also issued an updated draft guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).”

All

Latest

IntriCon Provides Insights into OTC Hearing Aid Market; Experiences Some Headwinds in Q2 2019

The company is bullish on the prospects of the upcoming OTC hearing device regulations from FDA, which it anticipates being issued this November and implemented in mid-2020. In his comments to investors, IntriCon CEO Mark Gorder was also optimistic that the new OTC hearing device regulations would be more liberal relative to the amount of allowable gain and for whom the devices might be intended.

All

Latest

Coupler and Real-Ear Performance between PSAPs and Hearing Aids

Before jumping to the conclusion that any PSAP and/or future OTC hearing device would be suitable for the many different types of hearing losses, we need to look at their coupler and real-ear performance data. This study by Adam Voss, Kristi Oeding, AU Bankaitis, John Pumford, and Michael Valente suggests current PSAPs are suitable for mild losses only.

Staff Standpoint: The Invisible Hand

The fourth quarter (Q4) of 2015 marked strong growth for the private sector, with an 8.2% increase in sales compared to Q4 2014. The VA increased its dispensing activity by 2.3%. Total hearing aid unit sales grew by 7.0% in Q4 2015. What is not known is how much private sector growth can be attributed to the market gains of low-cost retailers like Costco.

Read More

HLAA Supports Recommendations of PCAST Report on Hearing Loss

The Hearing Loss Association of America (HLAA), a national organization representing people with hearing loss, has announced that it enthusiastically endorses a new report issued by the President’s Council of Advisors on Science and Technology (PCAST). This announcement comes on the heels of an announcement from HIA, which strongly opposes the PCAST recommendations.

Read More
Loading