The Audiologist Informer

The new company now led by Burke says it intends to “disrupt and reshape the legacy hearing aid market.” It includes several hearing industry veterans who have previously worked at well-known firms, including Dan Thomas (formerly with GN, Beltone, and Starkey), Steve Warwick (MDHearing), and Keith Guggenburger (Starkey), and lists Nano hearing aids, "Home & Away", and "Audacity" as its upcoming multi-branded direct-to-consumer products.

The researchers found that diabetes, hypertension, smoking, and drinking were not significantly associated with SSNHL among 255 SSNHL patients and an equal number in the control group. However, increased tendency for blood clotting (hypercoagulability due to a higher level of blood fibrinogen) and inner-ear clotting (microthrombosis) were found as possible risk factors, along with inflammation (e.g., elevated white blood cell count), in SSNHL onset.

The FDA will now require medical devices to meet specific cybersecurity guidelines as a growing number of internet-connected products and systems used by hospitals and healthcare providers have been hit by hacks and ransomware attacks. It would appear all future premarket notifications for medical devices will need to address the new requirements, although HT is looking into the specifics for hearing care.