{"id":31600,"date":"2021-08-17T02:45:19","date_gmt":"2021-08-17T02:45:19","guid":{"rendered":"https:\/\/www.nuheara.com\/usa\/?p=31600"},"modified":"2021-11-22T19:53:00","modified_gmt":"2021-11-22T19:53:00","slug":"nuheara-to-commence-medical-device-trial","status":"publish","type":"post","link":"https:\/\/www.nuheara.com\/usa\/news\/nuheara-to-commence-medical-device-trial\/","title":{"rendered":"Nuheara to commence Medical Device Trial"},"content":{"rendered":"

Nuheara Limited (ASX: NUH<\/a><\/strong>) (Company<\/strong> or Nuheara<\/strong>), transforming the way people hear by creating smart and affordable hearing solutions, is pleased to announce that it will commence a clinical trial to test the safety and effectiveness of Nuheara\u2019s newly developed range of hearing aid products, to support Nuheara\u2019s planned expansion into clinically tested and regulatory approved medical devices.<\/p>\n

Nuheara has engaged National Acoustics Laboratories (NAL<\/strong><\/a>) under the terms of a Clinical Trial Agreement (CTA<\/strong>), the pricing of which is not considered material, to assist with conducting the clinical trial.<\/p>\n

The results of the clinical trial will allow Nuheara to expand its global hearing solutions by meeting hearing aid compliance requirements initially with the U.S. Food and Drug Administration (FDA), the European Union (CE Mark) and the Australian Therapeutic Goods Administration (TGA).<\/p>\n

Commenting on the medical device clinical trial, Nuheara Co-founder and CEO Justin Miller said: \u201cThis clinical trial is the first step of our evolution to a medical device company, specifically in the over US$8 billion regulated global hearing aid market\u00b9.\u00a0 Our breakthrough hearable products, which are non-regulated, have laid a solid foundation for our technology and future products to operate in.\u201d<\/p>\n

Nuheara\u2019s CTA project team is led by US based audiologist and clinical\/regulatory consultant, Deborah Arthur.\u00a0 Ms Arthur has been providing regulatory, clinical, and quality leadership over the last 30 years in the medical device environment, shepherding novel products, especially for Ear, Nose and Throat (ENT) applications, through the regulatory approval process including the De Novo<\/em> hearing aid applications for Earlens Corporation and Bose Corporation. \u00a0She has previously held executive management roles in regulatory, clinical, and\/or quality at Cochlear Americas, MED-EL NA, Smith & Nephew, Symphonix Devices, Inc, and MetaCure Inc.<\/p>\n

As previously announced, Nuheara has registered its company with the FDA\u00b2.\u00a0 A successful medical device clinical trial will provide Nuheara with the basis to enter any regulated hearing device market, globally.\u00a0 It will also provide potential pathways for the Company to enter the Over-The-Counter (OTC) hearing aid market as the FDA releases their OTC guidelines, expected in October 2021.<\/p>\n

The detailed structure of the trial is being determined by Nuheara and NAL and will be responsive to trial results and circumstances; NAL is developing detailed protocols for the trial. \u00a0The Company expects to provide updates to the market as it reaches relevant milestones throughout the clinical testing including ethical approval, recruitment, trial commencement, and results.\u00a0 The timing of those milestones will depend on the success or otherwise of the trial.\u00a0 As is usual for clinical trials of this type, the ethical approval will be sought externally, in this instance from the Hearing Australia Human Research Ethics Committee.<\/p>\n

-ENDS-<\/p>\n

References:<\/p>\n

1 \u2013 Fortune Business Insights, Oct 2019<\/p>\n

2 \u2013 NUH ASX Release, \u201cNUH receives FDA Registration and Hearing Aid Device Listing\u201d, 9 March 2021<\/p>\n\n\n\n\n\n\n
AUTHORISED BY<\/strong>:<\/strong><\/td>\nINVESTOR AND MEDIA ENQUIRIES:<\/strong><\/td>\n<\/tr>\n
Justin Miller<\/td>\nRonn Bechler, Market Eye<\/td>\n<\/tr>\n
Managing Director and CEO<\/td>\nEmail: ronn.bechler@marketeye.com.au<\/a><\/td>\n<\/tr>\n
Nuheara Limited<\/td>\nPhone: + 61 400 009 774<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

ABOUT NUHEARA<\/p>\n

Nuheara is a global leader in smart hearing technology which change people\u2019s lives by enhancing the power to hear. Nuheara has developed proprietary, multi-functional, personalised intelligent hearing devices that augments a person\u2019s hearing. \u00a0Nuheara is headquartered in Perth, Australia and was the first consumer wearables technology company to be listed on the Australian Stock Exchange (ASX).<\/p>\n

In 2016, the Company released its revolutionary wireless earbuds, IQbuds, which allow consumers to augment their hearing according to their personal hearing preferences and connect hands free with their voice-enabled smart devices. In 2020 Nuheara released its third generation IQbuds\u00b2 MAX.\u00a0 Nuheara products are now sold Direct to Consumer (DTC) and in major consumer electronics retailers, professional hearing clinics, pharmacies and optical chains around the world.<\/p>\n

The Company\u2019s mission is to transform the way people hear by creating smart hearing solutions that are both accessible and affordable.\u00a0\u00a0 For further information, please visit https:\/\/www.nuheara.com\/<\/a>.<\/p>\n

ABOUT NATIONAL ACOUSTICS LABORATORIES<\/p>\n

The\u00a0National Acoustic Laboratories<\/strong>\u00a0(NAL) is the research division of\u00a0Hearing Australia.\u00a0Hearing Australia is a statutory body established under the Australian Hearing Services Act 1991. Since 1947, NAL\u2019s research into hearing has opened new ways in which people with hearing problems can be helped.<\/p>\n

NAL researchers carry out research within four departments:<\/p>\n