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

MED-EL USA announced the FDA approval for the use of their cochlear implants for single-sided deafness and asymmetric hearing loss for patients 5 years of age and older on July, 22, 2019. The data from the clinical trial on cochlear implantation in cases of single-sided deafness and asymmetric hearing loss conducted by Margaret Dillon, AuD, and the UNC Cochlear Implant Clinical Research lab was instrumental in the FDA approval.

FDA Approves Cochlear Implantation for Single-Sided Deafness and Asymmetric Hearing Loss click to enlarge Margaret Dillon, AuD, Associate Professor, Director of Cochlear Implant Clinical Research

“Patients with single-sided deafness and asymmetric hearing loss experience difficulty with speech understanding in noise and localizing sounds in their environment,” said Margaret Dillon, AuD, Associate Professor, Director of Cochlear Implant Clinical Research, and Principal Investigator on the clinical trial. “Our data demonstrated early, significant benefits with cochlear implant use on measures of speech understanding in noise, localization, and subjective benefit.”

Single-sided deafness and asymmetric hearing loss affects people in all stages of life. This is extremely challenging for patients and can affect their quality of life. One participant in the clinical trial, Mitch, lost his hearing suddenly in one ear following a traumatic accident at the age of 21. Mitch was faced with not only recovering from skull fractures and cranial bleeding but also resultant single-sided deafness, vertigo, and tinnitus. He did not experience benefit with the approved treatment options for single-sided deafness at that time. Mitch pursued an evaluation with the UNC Cochlear Implant Clinical Research team in 2015, enrolled in the clinical trial, and underwent cochlear implantation. After only one month of cochlear implant use, Mitch demonstrated significant improvements in speech understanding in noise and localization of sound. He also reported significant improvements in his quality of life. Today, Mitch wears his cochlear implant daily and continues to have notable benefit with the device.

After demonstrating the significant benefit of cochlear implant use in adult subjects, the UNC Cochlear Implant Clinical Research Lab initiated a clinical trial on cochlear implantation in cases of single-sided deafness in children. Sam, a pediatric subject, suffered from single-sided deafness at a very young age. He was typically outgoing and social, until he began to struggle at the age of four due to his resultant hearing loss from an infection following surgery. Sam could not localize sounds or function in loud environments because the different sounds became too much for him to process with only one normal-hearing ear. He transformed into a shy preschooler and isolated himself. After the family’s local physicians said nothing could be done for Sam medically at their center, Sam’s hearing intervention teacher referred the family to the Children’s Cochlear Implant Center at UNC. In 2017, Sam underwent cochlear implantation by Kevin Brown, MD, PhD, Associate Professor, Chief of Otology/Neurotology, Skull Base Surgery, and Medical Director of the Children’s Cochlear Implant Center at UNC, and Principal Investigator on the pediatric clinical trial. Sam’s surgery was a success and he has returned to his outgoing self; he utilizes his cochlear implant daily and at the age of seven, has experienced notable improvements in his hearing and quality of life. Read more about Sam and his journey here.

The UNC Cochlear Implant Clinical Research team is grateful to the clinical trial participants. It is because of their participation that the indications for cochlear implantation have expanded and more patients who are struggling with single-sided deafness and asymmetric hearing loss may benefit from this intervention.

You can read the press release here.

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