Search Results for: otc

A Perspective on the Indiana University OTC Outcome Study

There is much to be learned from the recent IU study on OTC hearing aids. However, as its authors state, the findings are specific to that study and should not be generalized to the population of hearing-impaired individuals at large. A comparison is offered here to an audiology clinic using best practices. Results indicate that removing the professional from the fitting and follow-up process yields significantly lower levels of benefit, satisfaction, and use. If OTC hearing aids become a reality, this should be clearly stated on advertising and packaging; consumers should be informed that research has shown 45% of individuals returned hearing aids that were self-fit. Improving accessibility and affordability is only worthwhile if use and satisfaction are not sacrificed in the process.

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ADA to Host Audiology Hackathon for Promoting Hearing Awareness; Incorporating OTC Devices

The Academy of Doctors of Audiology will host a 3-part online Audiology Hackathon series to bring audiologists, students, consumers, and other experts together virtually, for the purpose of addressing specific issues and to foster greater awareness and action around hearing health as a public health concern. The series starts on July 23.

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OTC, Hearing Aids, and Cost as a Barrier to Purchase: An Interview with Amyn M. Amlani, PhD

The argument that a new FDA class of OTC hearing aids will dramatically expand the hearing healthcare market by making hearing aids more affordable is often taken as a “given.” However, research into what economists call “price elasticity”—or how much growth occurs in terms of market penetration when the cost of a product is reduced/increased—tend to suggest otherwise when it comes to hearing aids.

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NASEM Committee Looks at Regulations for OTC Hearing Devices

The June 9 Dissemination Meeting featured a wide menu of possible regulations for a new OTC category of hearing devices, and the meeting concentrated on safety and quality control, as well as packaging and labeling requirements. The NASEM meeting’s proposals are not part of the FDA’s formal rule-making process, but they could serve as a starting point for considerations by FDA and discussions with stakeholders in hearing hearing healthcare when formulating a possible new OTC hearing device category.

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AudiologyNOW! 2017 Dominated by OTC Discussions

The AudiologyNOW! 2017 convention theme, “Connect, Reconnect, and Innovate in INDY!” reflected the Academy’s desire for its members to forge new relationships, strengthen existing ties, and learn about new technology during the 4-day conference in Indianapolis. However, talk about over-the-counter hearing aids and potential changes in hearing healthcare dominated discussion at the event.

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OTC Hearing Aid Act Bundled with MDUFA; Expected to Pass through Committee

The Over the Counter Hearing Aid Act of 2017 is expected to pass through the Senate Health, Education, Labor & Pensions (HELP) Committee as part of the much larger Medical Device User Fee Amendments (MDUFA) package. Although the current bill continues to allow OTC devices to apply to “mild-to-moderate” hearing losses, the severity of hearing loss remains a primary sticking point for the bill.

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