FDA Formally Classifies Active Noise Attenuation Systems for Infant Incubators as Class II Devices
The regulatory action clears a pathway for future manufacturers to bring noise-canceling incubator systems to market through a less burdensome route.
The regulatory action clears a pathway for future manufacturers to bring noise-canceling incubator systems to market through a less burdensome route.
Poll data from ASHA's campaign shows audiologist and SLP intervention significantly improves outcomes for patients and their caregivers.
In a pivotal trial, 42% of participants achieved normal hearing using the gene therapy indicated for pediatric and adult patients with severe-to-profound hearing loss due to biallelic OTOF gene variants.
The WSA Sound Preference program aims to reframe hearing aid counseling to include identifying individual sound preferences and thereby enable more personalized fittings, improved patient engagement, and better hearing aid satisfaction, and increase adoption.
Frank Lin, MD, PhD, discusses the Know Your Hearing Number campaign and why this concept can help break down barriers to hearing care.
Developed by the National Acoustic Laboratories, the system builds on NAL-NL2 and is designed for more precise, personalized hearing aid fittings.
The IotaSoft robotic-assisted cochlear implant insertion system is now cleared for use in children aged four and older.