The tiny private company EarLens is unlikely to challenge large hearing aid providers for dominance of the $5bn US hearing aid market, but its technology is certainly unlike anything they can offer. The EarLens Contact Hearing Device, which has just been granted US de novo clearance, uses a laser diode as part of the sound transmission process.
The group says this enables better performance than anything else on the market, enabling users to hear a wider range of frequencies. Perhaps this will be enough of a selling point to allow it to make decent sales, although this will depend on the reimbursement situation. Alternatively, a high-end product might appeal to one of the other players in this space, precipitating a buyout.
The EarLens device is placed in contact with the patient’s eardrum – to which it is custom moulded – via a non-surgical procedure that takes place in the doctor’s office. A small photoreceptor faces out into the ear canal.
A probe terminating in a laser diode is then placed in the ear canal, connected to an audio processor that sits behind the ear. A microphone on the processor detects sound and converts it to electrical impulses; these are in turn converted into flashes of light, transmitted through the canal. These are detected by the EarLens, which vibrates against the eardrum; the patient perceives these vibrations as sound.
This is the first time that the FDA has permitted sale of a hearing aid that uses light to transmit sound. The device is indicated for use by adults with mild to severe sensorineural hearing impairment.
Around 37 million adults in the US report some form of hearing loss, but only 30% of those over 70, and 16% of adults aged 20 to 69 who could benefit from wearing hearing aids, have ever used them. EarLens must hope that this cohort find its technology more appealing than existing devices.
EarLens says its device permits patients to hear a wider range of frequencies than other hearing aids, with clinical data showing clinically significant improvements in hearing high and low-pitched sounds. These improvements cannot be matched by other hearing aids, the company says.
One aspect of the US market that could favour EarLens is that 78% of sales are to the private market; Medicare does not cover hearing aids. The only US patients to have their hearing aids paid for by the government are forces veterans.
This means that patients can exercise a lot of choice over which hearing aid they buy, and if a device with a technological advantage is marketed correctly it can achieve rapid uptake. Analysts at Bernstein say the US is the largest market in the world for hearing aids, and also one of the most dynamic, with a rapidly evolving retail landscape.
Still, it is dominated by the three large manufacturers: GN Store Nord had 42% of the US market in 2014, Bernstein analysts say, followed by William Demant with 34% and Sonova with 32%.
GN Store Nord is known for offering innovative devices though its GN ReSound unit, but all of them sell a range of products from entry-level to premium. As a result, any one of these groups might see an advantage in buying EarLens.