Tuesday, July 23, 2019

First Cochlear Implants FDA Approved for Single-Sided Deafness Asymmetric Hearing Loss

MED-EL USA just announced that its SYNCHRONY and SYNCHRONY 2 cochlear implants received the first FDA approval for people with single-sided deafness (SSD) and those with asymmetric hearing loss (AHL). No other cochlear implants currently have such an indication, so this latest news is a big deal for millions of people suffering from SSD and AHL.

Some data from the study that led to the approval, according to MED-EL:

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…

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.

Product page: SYNCHRONY

Flashbacks: MED-EL Corporation’s new Cochlear Implant System; FDA Hands MED-EL Approval for MRI Compatible Cochlear Implant


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