The Hearing Industries Assn. conveyed its concerns with the FDA’s approval of Bose Corp.’s self-fitting hearing aid. In October 2018, the FDA granted Bose de novo clearance for the over-the-counter device billed as the first of its kind on the U.S. market, according to the FDA’s Center for Devices & Radiological Health. In a May […]
Hearing
7 wearable medtech companies to see at the Wearable Technology Show
Wearable devices aren’t going anywhere anytime soon in the world of medtech. The Wearable Technology Show 2017 is taking place March 7 and March 8 at the Excel in London, offering a chance to check out some of the latest wearable devices. Digital health technology, smart textiles and sensors, and augmented reality are just some of the […]
Cochlear dips on slumping China sales
(Reuters) — Cochlear Ltd. (ASX:COH), the world #1 hearing implants maker, yesterday posted record half-year profits on a robust U.S. sales, but a slump in China tender orders pushed its share price more than 3% lower when the market closed Down Under. Although Cochlear has come back from a damaging recall in 2011 to book strong results over the […]
Clearwater Clinical raises $6m Series A for Shoebox table audiometer
Clearwater Clinical said today that it raised a $6 million Series A round for its Shoebox tablet-based audiometer, taking its total raise to nearly $10 million. The round was led by Toronto’s Whitecap Venture Partners, with participation from BDC Capital Healthcare Venture Fund. Clearwater said it plans to work closely with Whitecap on product development, go-to-market […]
Appeals court reverses Cochlear win in Advanced Bionics patent spat
A federal appeals court last week overturned a win for Cochlear Ltd. (ASX:COH) in its patent spat with Advanced Bionics over hearing implant technology, sending the case back to district court for reconsideration in light of a recent U.S. Supreme Court decision. The cochlear implant patents were licensed to Advanced Bionics by the Alfred E. Mann Foundation, named […]
Natus puts up $145m for GN Otometrics, cuts guidance on shipment hold
Shares in Natus Medical (NSDQ:BABY), which said today that it agreed to put up $145 million for GN Store Nord‘s (CPH:GN) otometrics hearing and balance diagnostics business, plunged today after Natus cut its 3rd-quarter guidance due to a voluntary shipment hold at its Seattle facility. Pleasanton, Calif.-based Natus said it plans to fund the GN Otometrics […]
William Demant moves hearing aid production from U.S., Denmark to Poland, Mexico
William Demant (CPH:WDH) plans to shift production from the U.S. and Denmark to Poland and Mexico to cut costs by around $30 million (DKK200 million) a year, the Danish hearing aid maker said today. A plant in Eagan, Minn., has already closed and operations in Thisted, Denmark, are slated to be moved to Poland before the end of 2018, meaning job cuts for […]
Medtronic, Cochlear get in on $51m Earlens round
Earlens said today that it raised a funding round worth $51 million for the light-driven hearing aid it developed, pulling down $34 million in cash and another $17 million in a bridge financing conversion. The Earlens device, which last October won 510(k) clearance from the FDA, uses a laser diode attached to a behind-the-ear audio processor to […]
Sonova buys AudioNova in $953m deal
(Reuters) — Swiss hearing aid maker Sonova Holding AG (SIX:SOON) is buying Dutch-based AudioNova for €830 million ($953 million), its largest acquisition, to expand a network of European stores where it will jettison rivals’ products in favor of its own. The cash deal to buy AudioNova from Curacao-based investment company HAL Holding N.V. will add 1,300 […]
Cochlear wins FDA clearance for Baja 5 SuperPower sound processor
Cochlear Ltd. (ASX:COH) said today that the FDA cleared its Baha 5 SuperPower sound processor, which is designed to treat higher degrees of mixed hearing loss. The device allows users to stream audio directly from Apple devices including the iPhone, iPod Touch and iPad, via Bluetooth, the Centennial, Colo.-based company said. “The FDA clearance of the […]
Gene therapy for deafness moves a few steps closer
(Reuters) — Gene therapy for deafness is moving closer to reality, with new research yesterday showing the technique for fixing faulty DNA can improve responses in mice with genetic hearing loss. Separately, a clinical trial backed by Novartis (NYSE:NVS) is under way to help a different group of people who have lost their hearing through […]