Australian-based wireless earbud company, Nuheara, which recently announced product expansions and a unique partnership with the National Acoustics Laboratories and HEARing CRC, also made news last month when they reportedly petitioned the FDA to expedite the implementation of the Over-the Counter (OTC) Hearing Aid Act legislation, signed into law by President Trump in August 2017.
It was also reported by HHTM in February that Nuheara’s soon-to-be-launched IQbuds Boost earbuds are purportedly the only product on the market at this time adhering to the American OTC Act requirements.
OTC Hearing Aid Reimbursement for the Aussie’s?
On March 16, Nuheara announced that it has successfully registered as an approved supplier to the Australian Government’s Hearing Services Program (HSP). The announcement of this supplier agreement caused Nuheara to experience an immediate 26% increase in its stock. Nuheara is reported to be the first wearables technology company to be listed on the Australian Stock Exchange (ASX).
The Australia’s Hearing Services Program (or HSP) allows eligible Australians access to free and subsidized hearing devices and related services. During the 2017-18 Federal budget the HSP was allocated $539 million of funding. This figure is expected to rise to $566 million for 2018-19.
The Company will place both IQBuds and IQBuds Boost on the Device Schedule as Assisted Listening Devices (ALD).
“Nuheara has been focused on bringing to market the most cutting-edge technology that enables hearing accessibility and affordability. With IQBuds Boost™, there is no other product on the market that allows you to take a clinically validated hearing test from the comfort of your own home and then automatically calibrates the device to your personalised hearing needs, using the globally renowned NAL-NL2 prescription procedure best known for fitting very expensive hearing aids.”
–Justin Miller, Nuheara CEO
A Different Tune on OTC in France
While it was announced that Nuheara’s products has become successfully registered by the Australian Government’s HSP, Audiology Worldnews announced on March 18 that the French Social Security system would not being offering reimbursement for OTC devices.
Recently, a company by the name of EvoluPharm announced that “Audibest by Louis,” billed by the company as “the first over-the-counter presbycusis device reimbursed by the (French) social security.” This announcement sparked concerns that hearing aids in France may become deregulated.
In its announcement the French National Health Insurance Body invited all parties to refer to its website where they posted this announcement:
“As it stands, in order to qualify for reimbursement, hearing devices from the official list of refundable products and services (LPP) must be delivered after a consultation with a hearing care professional and several patient listening sessions, as well as hearing tests and device tests and adjustments, which are all listed very explicitly. This (Audibest) device does not meet these conditions. It is an intermediate medical device, somewhere in between hearing aids, which are under the monopoly of hearing care professionals, and assistive listening devices, which are available in open distribution.”
According to French regulations, Products labeled as assistive listening devices cannot exceed 20 dB of amplification.
In what was characterized as a pithy statement by the Worldnews, the French National Union of Hearing Care Professionals (Unsaf) issued an explanatory note in the wake of the presentation of this product, reminding its members: “Some of you have forwarded information about so called ‘medical devices’ or ‘assistive listening devices’ which are presented as eligible for reimbursement and which can allegedly be sold by opticians or pharmacists without the intervention of a hearing care professional. This is absolutely false since any reimbursement of hearing aids is subject to its having been fitted and monitored by a hearing care professional.”
*featured image courtesy SAMHSA