On September 29, 2015 the FDA announced the clearance of the EarLens Hearing System through the 510(k) De Novo process. That announcement and associated media coverage, including a September 30, 2015 article in The Hearing Review, generated significant interest. In response to the many questions it received following the FDA announcement, the EarLens Corporation recently issued additional information about its new hearing system, which is anticipated to reach the market in 2016.
The company reports that the EarLens Hearing System is the first hearing aid to use light to transmit sound. While traditional acoustic hearing aids do not require clearance from the FDA, the EarLens Hearing System uses a new and unique mechanism of sound transduction. This differentiation prompted the FDA to create a new class of hearing aid, exclusive to the EarLens Hearing System.
The EarLens Hearing System in action.
The system includes a small, custom lens that is placed on the eardrum by an Ear Nose and Throat (ENT) physician during a regular office visit, says the company. A behind-the-ear processor receives sound and relays it to a widely vented in-ear light tip. The light tip converts sound to light and delivers this light to the lens. The lens then directly activates the natural hearing system. This approach, which is designed to prevent the typical feedback loop that troubles traditional amplification, is intended to allow EarLens to achieve high gain values across a broad bandwidth (125-10,000 Hz).
According to EarLens Corporation, the pivotal trial for the EarLens Hearing System was focused on safety and efficacy. The system was demonstrated to be safe, as there were no significant changes in hearing thresholds. Additional testing proved that the system was effective at providing amplification to subjects, as word recognition scores increased an average of 33% after 30 days. Data also demonstrated good performance of the EarLens Hearing System, as patients experienced a maximum gain of 68 dB at 10,000 Hz.
EarLens Corporation was started by entrepreneur Rodney Perkins, MD, who also founded ReSound Corp. His goal with the EarLens Hearing System was to create a hearing aid technology that delivers natural sound quality to patients. Dr Perkins found that direct activation of the eardrum can produce rich, natural sound. EarLens initiated additional clinical trials in the summer of 2015, and is planning an early 2016 commercial launch of the system in the US through ENT and Audiologist channels.
The company noted that, because the product launch is still months away, updated materials are not yet available. However, the company has provided a link to a YouTube animation of how EarLens works.
Source: EarLens Corporation
Our local provider quoted a price of $12,000. They have only done this for one patient who returned them. The problem could have been the lack of experience of the provider. Who knows but this is not the way to sell these.
Does Earlens help people with a lost of high frequency sound?
With an ENT involved would insurance cover some or all of the expense?
Insurance coverage
Iphone connect?
Cost
HOW MUCH?!
Would like a price on this aid
Would like to have an estimate how much Earlens costs.
I am Currently wearing the Lyric. I have endless issues with feedback. What’s important to me is having something that is more discreet then anything. As long as it works and there is no feedback, I would be thrilled. My only issue from what I’ve seen in your YouTube clip is that the receiver behind the ear looks quite noticeable. Will there be different sizes or possibly a much smaller strip that’s near invisible to replace the big plastic device?
I called 2 places to get the price of Earlens and there was a $500 difference at each place. Can somebody tell me how much it is for each ear? Thank you.
Hi Reza, How much were the Earlens aids? And, was the price difference caused by the surgeon to fit the aid?
How much is the hearing aid
I wear hearing aids and I am interested in this new product. Cost is important to me, as is the life of the aid.
Is Ear Lens Corp. a publicly traded company, if so what is the ticker symbol?
Thank you
EarLens Corporation is a privately held medical device company headquartered in Menlo Park, California. Here is a link to their website for more information: http://www.earlenscorp.com/company/company/
I have a moderately severe hearing loss and I feel pressure with traditional hearing aids, so I don’t wear them much. This system with a large venting gives me hope. Please keep me updated.