Tag: PSAPs

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 As hoped, the FDA also issued an updated draft guidance, “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).”

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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.

Teleaudiology: Friend or Foe in the Consumerism of Hearing Healthcare?

In Part 2 of this 2-part article, Tammara Stender, Jennifer Groth, and David Fabry address how teleaudiology can provide better fit-to-preference and efficiency in hearing healthcare. Today’s wireless and hearing instrument technology affords HCPs even more opportunities to quickly meet hearing needs. The obvious solution to the “user fit-to-preference versus time constraints for both users and professionals” dilemma is a hearing fitting protocol that marries the personal and professional interactions so important for user satisfaction with the convenience of user-driven services, such as apps or secure cloud connections.

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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.

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