• Nuheara has petitioned US FDA Commissioner for OTC Hearing Aid Act to be expedited.
  • OTC Act designed to unlock more affordable and accessible hearing health care.
  • Regulations for OTC hearing device has been charged to FDA to complete within three years.
  • OTC Hearing Aid has accessibility and affordability intentions that will be met with IQbuds Boost.

22 February 2018 – Perth, Australia

Nuheara Limited (ASX: NUH) (“Company” or “Nuheara”), a global leader in Intelligent Hearing: smart personal hearing devices that enhance and amplify human experiences, is pleased to advise that its EAR ID™ hearing assessment procedure has been clinically validated by the National Acoustic Laboratories (NAL) www.nal.gov.au.

Nuheara has developed a new proprietary and innovative technology process called Ear ID™, which via assessment creates a unique personal hearing profile by evaluating the users’ own hearing capabilities.

Nuheara engaged Australia’s world-leading hearing research organisation NAL, to conduct a clinical study to examine the validity and reliability of Ear ID™ automated hearing assessment technology for its new product IQBuds Boost™.

The Ear ID™ hearing assessment was shown to be as reliable as conventional clinical audiometry when conducted in a quiet environment. 97.5% of hearing thresholds derived by the Ear ID™ system were within 5dB of those measured on subsequent retests. Clinical audiometry includes such factors as having an audiologist conducting the hearing assessment, meaning that Nuheara has now broken the threshold of how hearing assessments can be reliably completed, and hearing devices configured, with the use of automated technology.

These results indicate a high level of repeatability of threshold determination using the technology.

“While the tests were done in a quiet controlled environment, these results are quite impressive,” said Elizabeth Beach, PhD and NAL Senior Researcher.

“Without a doubt, Nuheara is breaking new ground in this emerging product category and we are incredibly pleased with the outcomes of the study,” said Alan Davis PhD, Nuheara VP of Product. HE continued:

“Ear ID is a sophisticated technology stack that incorporates our proprietary hearing assessment tech with the NAL-NL2 non-linear prescription procedure that is then used to calibrate IQbuds Boost™. Partnering with NAL to validate the reliability of our proprietary hearing assessment technique provides a crucial scientific foundation for our technology offerings now and into the future.”

Nuheara is continuing development and improvements of Ear ID™ and will deploy future versions into Nuheara’s upcoming IQbuds Boost™ product.

More about the study:

The aim of the study was to determine whether Nuheara’s technology produces accurate hearing thresholds for individuals whose hearing is in the Ear ID’s target fitting range.

The evaluation was conducted independently by NAL at its Sydney research facility by university qualified research audiologists.

Thirty participants undertook audiometric testing using standard clinical methods and also measured their hearing thresholds with a pre-release version of Nuheara’s Ear ID™ hearing assessment technology in the same laboratory environment.

All participants were able to complete the Ear ID™ self-assessment process with minimal direction from the audiologist, and the majority of participants could derive accurate hearing thresholds using Ear ID for the frequencies tested in the study. Almost 70% of thresholds agreed exactly with those obtained using conventional audiometry.

In addition to comparing individual thresholds, four frequency average hearing thresholds (4FAHLs) were calculated for each method and compared as another measure of test validity. For 87% of participants, 4FAHLs calculated from the Ear ID assessment were within 5dB of those for the audiologist-administered hearing test. For the remaining 13% of cases, 4FAHLs from the Ear ID test were within 7.5dB of the audiologist-administered hearing test.

About Nuheara
Nuheara is a global leader in Intelligent Hearing: smart personal hearing devices that enhance and amplify human experiences. Nuheara has developed proprietary and multi-functional intelligent hearing technology that augments a person’s hearing and facilitates cable free connection to smart devices. Nuheara is based in Perth, Australia and has offices in San Francisco and New York, USA. Nuheara was the first consumer wearables technology company to be listed on the Australian Stock Exchange (ASX).

In 2016, the Company released its revolutionary wireless earbuds, IQbudsTM, which allow consumers to augment their hearing according to their personal hearing preferences and connect hands free with their voice-enabled smart devices. IQbuds™ are now sold in major consumer electronics retailers and professional hearing clinics around the world. The Company’s mission is to improve people’s lives by allowing them to seamlessly listen, communicate, and connect to their physical and digital worlds.

Learn more about Nuheara: www.nuheara.com

About NAL
The National Acoustic Laboratories (NAL) is the research division of Australian Hearing, a Statutory Authority under the Commonwealth Department of Human Services. Since 1947, NAL’s research into hearing has advanced the scientific understanding of the needs of those with hearing difficulty and how to help them. NAL also develops hearing health-related technologies and clinical practices that help people with hearing loss, the professionals who treat them, and the companies that develop hearing health solutions.

Learn more about NAL: www.nal.gov.au

February 22nd, 2018