MED-EL USA announced that its SYNCHRONY and SYNCHRONY 2 cochlear implants have won the first FDA approval for people with single-sided deafness (SSD) and those with asymmetric hearing loss (AHL). This is the first and only time that cochlear implants have been approved for these indications in the United States, so this news is a big deal for millions of people suffering from SSD and AHL., reports MedGadget.
“People living with single-sided deafness and asymmetric hearing loss have had limited technology options to improve their speech understanding, ability to localize sounds in their environment, and quality of life,” said Margaret T. Dillon, AuD, Associate Professor, Director of Cochlear Implant Clinical Research, and lead researcher on the SSD and AHL clinical trial at the University of North Carolina School of Medicine that was instrumental in the FDA approval. “Difficulty in speech understanding in noise and localizing sound are incredibly frustrating aspects of single-sided deafness and asymmetric hearing loss, and it was gratifying to be able to demonstrate the efficacy of MED-EL’s cochlear implants to help patients restore a sense of sound that they had been missing.”
SSD and AHL can be caused by viral infections, Meniere’s disease, or trauma to the head or ear. In some cases, the causes of SSD or AHL are unknown.
People with SSD and AHL experience difficulties hearing in certain listening situations such as noisy environments, and these difficulties have a negative impact on communication and social interaction. SSD can negatively affect speech and language development in children and work performance among adults.
Basis for the FDA Approval
The approval was based on clinical data from a study at the University of North Carolina at Chapel Hill with 40 participants ages 18 and older to evaluate speech perception in quiet and noise, sound localization and quality of life. Trial participants had single-sided sensorineural profound hearing loss in one ear, or asymmetric hearing loss, for less than 10 years and had used a hearing aid regularly for at least some of that time, the company said in a press release.
Both groups of people (SSD and AHL) improved their ability to understand speech in quiet after one year of implant use when tested with the implant alone. For the people with SSD, average scores when repeating single words in quiet increased from 4% before surgery to 55% after 12 months of listening with the implant. For the group of people with AHL, this same test score improved from 6% to 56% in 12 months. In the opposite ear, there was no change in their score over time. When tested with both ears, there was no change compared to the score before surgery.
When listening to speech in noise, both SSD and AHL groups improved over the first 12 months of listening with the cochlear implant compared to their unaided scores before surgery. The average improvement in the SSD group increased from 38% to 47% in 12 months on the AZ Bio Test, speech and noise from the front. This group also had an average increase from 17% to 53% on the AZ Bio Test when speech came from the front and the noise was on the side of the normal hearing ear. The AHL group saw increases from 23% to 34% when speech and noise came from the front, and 6% to 29% when speech came from the front and noise was on the side of the better hearing ear, also on the AZ Bio Test.