MEDICAL DEVICE NEWS MAGAZINE

Tuesday, September 27, 2022

MEDICAL DEVICE NEWS MAGAZINE

|

Contact us 561.316.3330

FDA Approves Cochlear Nucleus Implants for Unilateral Hearing Loss/single-sided Deafness

Cochlear Limited (ASX: COH), the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval of Cochlear™ Nucleus® Implants for the treatment of unilateral hearing loss (UHL)/single-sided deafness (SSD).

Cochlear implants are already FDA approved for those with moderate to profound bilateral sensorineural hearing loss. With this approval, for the first time Cochlear can expand implantable treatment options for those with UHL/SSD to include cochlear implants.

UHL is classified as hearing loss in one ear and near to near-normal hearing in the opposite ear, and SSD is specific to individuals with severe to profound hearing loss in one ear and normal or near-normal hearing in the other ear. Every year, about 60,000 people in the United States acquire SSD.1

“It is not often that approvals to expand indications and increase awareness about effective treatments for hearing loss come along. Now with this approval, Cochlear is proud to offer the most hearing implant options available to those with unilateral hearing loss/single-sided deafness through our cochlear implant and bone conduction solutions,” said Christine Menapace, MA, Vice President, Clinical Affairs, Cochlear Americas. “It is important that those with this type of hearing loss recognize the impact to their lives and understand there are several options available to them, and we encourage them to talk to their hearing health professional today to find out what would work best for them.”

UHL/SSD can impact an individual’s quality of life, including mental fatigue because of increased listening effort, as well as impacts to understanding speech in noise and localizing where sounds are coming from.2-6 Hearing with both ears is important. Hearing with two ears helps one to identify sounds both near and far, as well as those that occur 360 degrees around the head.7

“Unilateral sensorineural hearing loss has continued to gain greater acceptance in the field as an indication for cochlear implantation,” said Dr. Kevin Brown, Vice Chair, Chief of Neurotology and Executive Director of the Children’s Cochlear Implant Center at the University of North Carolina. “With this approval, it is important my industry colleagues and I ensure appropriate clinical guidance on how to effectively introduce this cochlear implant indication, outline a model for selecting patients that will benefit, and ensure success after implantation.”

Cochlear will now support those with UHL/SSD by offering its cochlear implant, the Cochlear Nucleus System, and bone conduction solutions, the Cochlear Osia® System and the Cochlear Baha® System. Cochlear’s implantable hearing solutions restore access to sound to improve quality of life and meet the lifestyle needs and preferences of each individual recipient.

 

Medical Device News Magazinehttps://infomeddnews.com
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Must Read

Bentley Acquires the GoBack Catheter

Bentley notes this acquisition expands the company’s product portfolio, which is dedicated to improve the clinical outcomes of endovascular treatments, and because of this improving the patients’ quality of life.

RQM+ Acquires Jordi Labs

“As the only MedTech service provider rooted in almost 40 years of regulatory strategy, RQM+ is proud to now offer proprietary testing services for extractables and leachables, which gives our customers the fastest path to regulatory approvals,” said CEO Margaret Keegan. “

Össur Acquires Naked Prosthetics

It is a welcome addition to the Össur product portfolio as it strengthens Össur's upper limb product offering globally and allows Össur to address a broader group of amputees seeking to live a Life Without Limitations.

By using this website you agree to accept Medical Device News Magazine Privacy Policy