The United States Food and Drug Administration (FDA) allowed marketing of a new hearing aid that will potentially broaden sound amplification for those who have hearing impairment on Tuesday.
The EarLens Contact Hearing Device (CHD) is the first hearing device to use light to transit sound.
The combination of laser light pulses comes in contact with the eardrum to complete the process.
“For the millions of Americans with hearing impairment, hearing aids can significantly improve regular daily communications, as well as overall quality of life,” Dr. William Maisel, chief scientist in the FDA’s Center for Devices and Radiological Health said in a press release. “People with hearing impairment now have a new option that may help improve their hearing by amplifying sounds over a broad spectrum of frequencies.”
The EarLens CHD differs from other hearing aids because the tympanic membrane transducer (TMT), which is placed into the ear canal on the eardrum, is custom made to the patients allowing efficient amplification of sound.
According to a press release from the FDA, statistics compiled by the National Institute on Deafness and Other Communication Disorders said that 37.5 million adults aged 18 and older in America report some form of hearing loss.
"We believe this could be a real game-changer for hearing-impaired individuals," William Facteau, president and CEO of EarLens CHD said in a press release.
Only 30 percent of adults aged 70 and older and 16 percent of adults aged 20-69 who could benefit from wearing hearing aids have ever used them.
Over a four-month period, clinical data supporting the safety and effectiveness of the EarLens CHD included several assessments including hearing stability, improved word recognition and functional amplification.
The clinical data gained the ability to hear sentences and background noises compared to listening without any amplification.
Verline Jean, a second-year FAMU pharmacy student from Pompano Beach, Fla., expressed how the advancement in EarLens’ product can improve communication with the hearing impaired.
“Growing up in a family with someone who is deaf was always a setback, but I think this marketing for EarLens will help anyone dealing with this problem tremendously,” Jean said.
Studies showed that after 30 days of device use, the 48 subjects experienced, on average, a 33 percent improvement in word recognition.
EarLens has raised more than $36.3 million from investors, according to its February 2014 SEC filing.