Definitions and Disclaimers
Definitions and Clarifications
- 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.
- 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 the same type of technology/hardware found within standard rechargeable prescription hearing aids.
- Audiologists #1 recommended online hearing aid. This phrase is NOT claiming that ALL audiologists recommend Audien Hearing's devices as their #1 hearing aid. Audien is simply stating that some Audiologists have recommended Audien's products as their top choice for certain patients in the past. This statement does not apply to all patients of audiologists Audien has communicated with in the past, but instead refers to a few specific cases in which patients were recommended Audien's devices.
- Rated most comfortable hearing aid in 2019. This statement refers to a survey conducted by Audien Hearing in 2019 amongst their customers. Customers were asked to rate Audien's products against other hearing products they had used in the past for several factors. The results of this survey showed that the majority of customers rated Audien Hearing's devices as more comfortable than any other devices they had used in the past included in the survey, and therefore gave Audien the rating of "most comfortable hearing aid" in the year 2019 when the survey was conducted.
- Customers Report: It is the best 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.