Compliments are due to the FDA and its registrants for making available to the public in real time the information regarding its review of hearing aids. The transparency of the FDA review process is going to become of an increasingly greater significance as the FDA begins to implement recent legislation authorizing over the counter sale of hearing aids.
As of January 1, 2021 CRE will initiate the posting of most, if not all, FDA actions taken with respect to 510 (k) reviews of hearing aids. We have also provided a mechanism for public review and comment.
As this process matures we will have greater access to information basic to rendering any recommended additional reforms to the 510 (k) program. It appears at this writing, subject to additional review, that for all practical purposes the 510 (k) program is a self-certification program which is now light years ahead of the PSAPs (Personal sound amplification products) program because the public and expert stakeholders can now provide their expert views in this easily accessible forum.
There might be considered arguments in support of not regulating the PSAPs —which are not hearing aids— but it is not at all clear that they should not be subject to reporting requirements which would provide a basis for including them on this Interactive Public Docket.
The entries below are limited to reporting on hearing aids. See the public comments at the end of the post that follows.
FDA 510 (k) Clearances 2021: Hearing Aids
January 2021 None
February 2021 None
March 2021 None
April 2021 None
May 2021 One
June 2021 None
July 2021 None
August 2021 None
An Exemplary Submission (2019)
DEVICE: Earlens Contact Hearing Aid Earlens Corporation 510(k)
NO: K182480(Traditional)
ATTN: Judith A. Brimacombe PHONE NO : 650 7394462 4045 Campbell Avenue SE Menlo Park CA 94025
DECISION MADE: 25-JAN-19
510 (k) SUMMARY AVAILABLE FROM FDA SUBSTANTIAL EQUIVALENCE:
The Earlens Contact Hearing Aid has the same intended use and fundamental scientific technology as the predicate, the Wireless Earlens Light Driven Hearing Aid (K153634). In the same manner as its predicate, the Earlens Contact Hearing Aid directly vibrates the umbo of the tympanic membrane to transmit sound to the recipient. The modification to the Earlens Contact Hearing Aid involves the replacement of the infrared light link used to transmit power and data from the Ear Tip to the Tympanic Lens with a new method, resonant inductive coupling. Specifically, the laser emitter in the Ear Tip is being replaced with a parylene encapsulated transmit coil and the photodetector on the Tympanic Lens is being replaced with a parylene encapsulated receive coil. The inductive system does not require line of sight to ensure that the signal and power are transmitted, as is the case with the infrared light link. Therefore, the signal transmission with the inductive system is less affected by normal jaw movements when individuals smile or chew.
SUBSTANTIAL EQUIVALENCE:
The Earlens Contact Hearing Aid has the same intended use and fundamental scientific technology as the predicate, the Wireless Earlens Light Driven Hearing Aid (K153634). In the
same manner as its predicate, the Earlens Contact Hearing Aid directly vibrates the umbo of the tympanic membrane to transmit sound to the recipient. The modification to the Earlens Contact
Hearing Aid involves the replacement of the infrared light link used to transmit power and data from the Ear Tip to the Tympanic Lens with a new method, resonant inductive coupling. Specifically, the laser emitter in the Ear Tip is being replaced with a parylene encapsulated transmit coil and the photodetector on the Tympanic Lens is being replaced with a parylene encapsulated receive coil. The inductive system does not require line of sight to ensure that the
signal and power are transmitted, as is the case with the infrared light link. Therefore, the signal transmission with the inductive system is less affected by normal jaw movements when individuals smile or chew. All other components and mechanisms of action remain the same as those described in K15363 for the Wireless Earlens Light Driven Hearing Aid. The Earlens Contact Hearing Aid offers the same wireless connectivity to the user as the predicate, the Wireless Earlens Light Driven Hearing Aid. With this feature, the user can stream telephone calls, music, and other media froma cell phone or other mobile device directly to the Earlens Contact Hearing Aid via a Bluetooth low energy protocol.
I have searched for information relating to recall of hearing aids by the FDA, and anything related to 510(k) and mislabeling etc. There have been several hearing aid recalls and they have all been voluntary. I have provided some information with regards to the 510(k) and exempt process and hearing aid, but the overall question really is enforcement. Basically today anyone could design a hearing aid and register it under 510(k) exempt, and unless a serious injury occurs or a number of complaints were to be registered, there would be no oversight. There is very little (if any) oversight into the utilization of good manufacturing practices, do the products meet the FDA regulatory requirements, and are they properly labeled. In addition, since PSAPs are not covered by regulation, there is nothing to be found on these products.
Editor’s Note:
The above comment deserves a serious consideration. In one instance, the 510k pathway, we have self-reporting with no third party verification and in the second instance, PSAP, we probably have a race-to the bottom.