Blog Tag: de novo premarket review pathway
The U.S. Food and Drug Administration recently announced approval for Bose to market their Bose Hearing Aid. According to the press release, the Bose Hearing Aid, which was approved through the FDA’s De Novo premarket review pathway, is the first approved hearing aid that can be self-fit and adjusted by a user.
Malvina Eydelman, M.D., the Director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices at the FDA’s Center for Devices and Radiologic Health commented:
“Today’s marketing authorization provides certain patients with access to a new hearing aid that provides them with direct control over the fit and functionality of the device. The FDA is committed to ensuring that individuals with hearing loss have options for taking an active role in their health care.”
According to the press release, clinical studies found the self-fitting Bose Hearing Aid to yield comparable outcomes relative to those found using a professional fitting. The press release also reported that users generally preferred self-adjusted settings over those selected by a professional.
In a statement made to TechCrunch, Joanne Berhiaume, a spokesperson for Bose, stated:
“Now, the De Novo grant by the FDA validates that Bose technologies can be applied to help people with mild to moderate hearing impairment take control of their hearing. We look forward to bringing affordable, accessible and great sounding solutions to the millions of people who could benefit from hearing aids but don’t use them.”
The reSET® mobile app, developed by Pear Therapeutics, is approved to assist individuals undergoing outpatient therapy for alcohol, cocaine, marijuana, and stimulant addictions. The application is not intended for use in treating opioid dependence, however.
The reSET® application is designed to provide a form of treatment called cognitive behavioral therapy. It teaches SUD patients practical skills that help them abstain from using drugs and stick with their rehab programs, and provides a series of reward-based incentives. reSET® is not approved as a standalone treatment. Instead, it is designed to be used in conjunction with outpatient addiction therapy.
“This is an example of how innovative digital technologies can help provide patients access to additional tools during their treatment,” said Carlos Peña, Ph.D., M.S., director of the Division of Neurological and Physical Medicine Devices in FDA’s Center for Devices and Radiological Health. “More therapy tools means a greater potential to improve outcomes, including abstinence, for patients with substance use disorder.”
reSET® was reviewed through the FDA’s de novo premarket review pathway, a regulatory scheme for low- to moderate-risk devices for which there is no legally marketed predicate to which the device can claim substantial equivalence. The FDA reviewed data from a multi-site, unblinded 12-week clinical trial of 399 patients. In this trial, patients with alcohol, cocaine, marijuana, and stimulant SUD who used reSET® demonstrated statistically significant greater adherence to abstinence (40.3 percent) compared to patients not using reSET® (17.6 percent).
We believe that prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology and pain, and will become a vital part of tomorrow’s treatment paradigm across all disease areas.
Regulatory approval of reSET® may represent an important step forward in the use of mobile applications to treat people with psychological, neurological and substance abuse disorders.