Definitions & Disclaimers

Definitions and Clarifications

  1. Audien’s Use of the term "Hearing Aid." The use of the term "hearing aid" on the Audien Site is NOT intended in the technical, legal or medical sense. The term is used in an entirely colloquial manner, intended to refer to a device that “aids” one's hearing by use of personal sound amplifier.  Audien devices have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease.

As used on this Site, "hearing aid" is not intended to describe the Food and Drug Administration’s (FDA's) definition of “hearing aids,” found here, nor is it intended to refer to “OTC hearing aids,” as defined by the FDA here.  

 

“OVER THE COUNTER (OTC) HEARING AIDS”

The following is an excerpt from the National Institute of Deafness & Other Communication Disorders (NIDCD) for information about “OTC hearing aids”: 

"Leading experts in science, technology, and hearing health care have been working with researchers, health professionals, and consumers to find safe and effective ways to improve access to hearing health care for adults. They suggested changing some regulations that studies showed were barriers to adults getting the hearing help they need. They also recommended that the FDA create guidelines and quality standards for OTC hearing aids.

A law established on August 18, 2017, as part of the FDA Reauthorization Act of 2017, directed the FDA to create a category of OTC hearing aids for adults who might have mild-to-moderate hearing loss. As part of this process, the FDA must issue a proposed rule by August 18, 2020, and a final rule within six months of the close of the comment period on the proposed rule."  

Unfortunately, due to the COVID 19 crisis, the FDA has not yet released those regulations.  While Audien products may be able to fall within that category in the future, Audien does not claim that its products are “OTC hearing aids” as referred to by the FDA. 

 

  1. "The Best Rechargeable Hearing Aid" This statement refers to a review submitted to Audien Hearing in 2020 by one of their customers. It is not intended to imply that we are ranked the best rechargeable hearing aid over others; rather, we used quotes to convey that this statement is a review.
  2. Similar technology to $5000 hearing aids. When Audien Hearing refers to the technology found in $5000 hearing aids, they are referring to the standard items such as the microphone and rechargeable batteries found within both types of device. Audien does NOT claim its technology is the same as that found in expensive prescription “hearing aids.” However, Audien's hearing devices do contain a similar type of technology/hardware found within standard rechargeable prescription hearing aids. 
  3. Recommended by over 100,000 happy customers. This statement refers to an internal survey of around 170,000 Audien customers which found more than 100,000 Audien customers to recommend their products.
  4. Most comfortable hearing aid you'll ever try. This is not an objective statement and is intended to emphasize how comfortable we and many of our customers think the hearing aid is. In no way does this statement attempt to claim that this is rated the most comfortable hearing aid on the market relative to others or any other claims of that nature.
  1. Great hearing aid for tinnitus management Audien is NOT claiming that their products diagnose, cure, or treat the medical condition of tinnitus. This statement refers to feedback provided from thousands of Audien Hearing's customers. Customers reported to Audien Hearing that Audien's devices helped calm the symptoms of their tinnitus because they were now able to use Audien's devices to focus more on the sounds in their surroundings. As a result, the ringing in their ears felt as if it had decreased, even though medically there is no cure for tinnitus. Customers consistently reported that Audien's devices helped "alleviate," "calm," and "manage" the ringing in their ears from the medical condition known as tinnitus. Audien is simply conveying customer feedback as reported in thousands of instances. 



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