NUHEARA LIMITED overview

BELLEVUE, Wash., May 03, 2023 (GLOBE NEWSWIRE) -- Medical device and consumer electronics manufacturer, Nuheara Limited (ASX:NUH) (Company or Nuheara) is pleased to announce key executive appointments and associated restructure of its senior executive team. These changes cement the Company’s transformation over the past two years into a medical device manufacturer of world-first US FDA-cleared Over The Counter (OTC) Hearing Aids. A key part of this transformation has been the cornerstone...

Bellevue, Wash., Feb. 21, 2023 (GLOBE NEWSWIRE) -- Nuheara announces the commercial availability of its HP Hearing PRO self-fitting, air-conduction, OTC hearing aid through Fuel Medical member clinics in the US. Nuheara’s HP Hearing PRO is the first product cleared through the FDA’s 510(k) process for both 874.3325 self-fitting and the 800.30 OTC hearing aid classifications under a new product classification code “QUH”. The HP Hearing PRO is a CES ® 2023 Innovation Awards Honoree . Fuel...

LAS VEGAS, Jan. 03, 2023 (GLOBE NEWSWIRE) -- Nuheara , the smart-hearing company, today announced the commercial availability of its HP Hearing PRO . Consumers can now pre-order the HP Hearing PRO self-fitting, air-conduction, OTC hearing aid at www.HPhearingPRO.com and soon be able to purchase the product from any retailer carrying the product including Best Buy and Crutchfield. Nuheara’s HP Hearing PRO is the first product cleared through the FDA’s 510(k) process for both 874.3325...

Highlights Nuheara has signed a Memorandum of Understanding (MoU) with InnerScope, substantially increasing Nuheara’s points of sale Nuheara’s US FDA cleared HP Hearing PRO self-fitting hearing aid to be sold in c4,600 US retail stores (up from c300 currently) US FDA cleared self-fit hearing aids now being manufactured to fulfill initial orders from Best Buy and other US retail customers BELLEVUE, Wash., Dec. 12, 2022 (GLOBE NEWSWIRE) -- Medical device and consumer electronics manufacturer...

BELLEVUE, Wash., Nov. 17, 2022 (GLOBE NEWSWIRE) -- Nuheara today announced that it has been named a CES® 2023 Innovation Awards Honoree for HP Hearing PRO self-fitting OTC hearing aids. This year’s CES Innovation Awards program received a record high number of over 2100 submissions. The announcement was made ahead of CES 2023 , the world’s most influential technology event, happening Jan. 5-8 in Las Vegas, NV. The CES Innovation Awards program, owned and produced by the Consumer Technology...

Highlights Nuheara has received the historic and first of its kind FDA 510(k) premarket clearance for both an 874.3325 Self-fitting Hearing Aid and the 800.30 Over The Counter (OTC) hearing aid classification, making this notable clearance for what is termed as a “Self-Fitting Air-Conduction Hearing Aid, Over The Counter” with the unique product code “QUH” Nuheara plans to launch its Self-Fitting OTC Hearing Aid as the HP Hearing PRO HP Hearing PRO Self-Fitting OTC Hearing Aids include...

BELLEVUE, Wash., May 09, 2022 (GLOBE NEWSWIRE) -- Medical device manufacturer, Nuheara Limited (ASX:NUH) (Company or Nuheara) is pleased to announce a series of structural changes designed to advance the Company’s unique and growing US based hearing healthcare market opportunities: The appointment of John R. Luna as its global, US based, Chief Executive Officer; Co-founder and former CEO, Justin Miller, remaining as the Company’s Managing Director; Engagement of Roth Capital Partners LLC...

SAN FRANCISCO, Oct. 21, 2021 (GLOBE NEWSWIRE) -- Nuheara ( ASX: NUH ), the developer of smart and affordable hearing solutions that transform the way people hear, welcomes the U.S. Food and Drug Administration (FDA) issuing its landmark proposal intended to improve access to and reduce the cost of hearing aid technology for millions of Americans [1] . The U.S. FDA has proposed a rule to establish a new category of over-the-counter (OTC) hearing aids. In a world first, the new rule will allow...