Proposed CMS Rule on Hearing Devices Would Limit Patient Treatment Options, Reports Sonitus Medical

Jul 31, 2014, 16:10 ET from Sonitus Medical

SAN MATEO, Calif., July 31, 2014 /PRNewswire/ -- Recently the Centers for Medicare & Medicaid Services (CMS) published a proposal that would limit treatment options for patients with single-sided deafness.  The proposal, if finalized, would continue non-coverage of the SoundBite Hearing System and withdraw Medicare coverage for Bone Anchored Hearing Aids (BAHA).  If the proposal is implemented, Medicare would not cover any prosthetic treatment option for unilateral deafness, restricting patient access to care.  Non-Medicare patients may also lose access to these treatments since private payers often follow Medicare's lead. 

Sonitus Medical, makers of the SoundBite Hearing System, is very concerned about the effect that this proposal will have on patients, and is working closely with health care professional, patient, and other societies to correct it.  Amir Abolfathi, CEO of Sonitus Medical, states,

"At Sonitus we believe that single-sided deafness is a medical condition that needs to be treated. We believe that patients with single-sided deafness suffer from significant disability and as such deserve the right to choose their treatment from among proven technologies like the SoundBite.  We believe that these are medically necessary treatments that should be covered by Medicare.  We believe that through innovation we can both improve care and create more cost-effective options for patients.  And we disagree with the proposal and join the chorus of clinicians, patients, and innovators in supporting a change."

CMS has opened a comment period that ends at 5pm EDT on September 2, 2014 and will publish its final decisions on or around November 1, 2014. Take the opportunity to review the rule and submit comments so that your voice is heard. 

Read the proposal (see p89-91):
Submit comments to CMS:!documentDetail;D=CMS-2014-0092-0002

About the patients affected: Single-sided deafness is caused by tumors, infections, or other illnesses, and is characterized by a significant or permanent hearing loss in one ear and relatively normal hearing in the other ear.  The hearing loss is often caused by trauma, infections, or benign tumors, and patients suffer from reduced quality of life among other consequences.

About Sonitus and SoundBite: An innovation in hearing-loss technology, SoundBite transmits sound using the well-established principle of bone conduction to restore the perception of hearing in both ears. Unlike other devices that route sound through skull bones, SoundBite uses the patient's teeth to transfer sound from the impaired ear to the working ear.  This system removes the need for a surgical implant in the skull which eliminates the costs and complications of surgery.  SoundBite is FDA cleared for Single-Sided Deafness and Conductive Hearing Loss in patients age 18 and older.

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SOURCE Sonitus Medical