FDA Approves Cochlear Implants for Single-Sided Deafness and Asymmetric Hearing Loss

In July 2019, the FDA approved MED-EL USA’s cochlear implant (CI) system for the treatment of single-sided deafness (SSD) and asymmetric hearing loss (AHL) – the first and only time CIs have been approved for these specific conditions in the U.S.  

Potential causes of SSD and AHL include viral infections, Meniere’s disease and head trauma, but oftentimes the cause is unknown. An estimated 4.9 million American adults experience SSD, and until now treatment has been limited to hearing aids—which often provide little benefit for those with profound hearing loss in one ear.  

The FDA’s approval was based on a successful study conducted by the University of North Carolina at Chapel Hill. Forty participants with SSD or AHL were evaluated, with particular attention paid to speech perception in quiet and noise, sound localization and quality of life. The results over one year were significant:  

• Speech Perception in Quiet

• Scores for SSD patients improved from 4% to 55% understanding.
• Scores for AHL patients improved from 6% to 56% understanding.

• Speech Understanding in Noise

• Scores for SSD patients improved from 38% to 47% understanding.
• Scores for AHL patients improved from 23% to 34% understanding.

• Sound Localization

• Both groups self-reported significant improvement with Cis.

• Quality of Life

• Both groups self-reported significant improvement with Cis.

Patients ages five and older with SSD presenting as profound sensorineural hearing loss in one ear and normal hearing or mild sensorineural hearing loss in the other ear, as well as those ages five and older with AHL presenting as profound sensorineural hearing loss in one ear and mild to moderately severe sensorineural hearing loss in the other ear, specifically qualify for the SYNCHRONY and SYNCHRONY 2 CI systems, manufactured by MED-EL USA.  

For more information or to find out if CIs are right for you, schedule an appointment with your provider!  

Source: Golub JS, Lin FR, Lustig LR, Lalwani AK. Prevalence of adult unilateral hearing loss and hearing aid use in the United States. Laryngoscope. 2018 Jul;128 (7):1681-1686.