附件

共识声明资料：

The consensus paper is divided into five key recommendations:

1) Establish product requirements appropriate for OTC hearing devices targeting mild‐to‐moderate adult hearing impairment. Easily one of the most contentious issues in the OTC hearing aid debate is the amount of hearing loss and corresponding safe output limits for which the devices should be intended. The consensus paper uses the ASHA definition of mild-to-moderate hearing loss from 26-55 dB HL (a 30 dB range) which would easily cover the majority of people with hearing loss. It also recommends a high-frequency average full-on gain limit (HFA-FOG) of 25 dB (2cc coupler), with an input level of 50 dB SPL. Additionally, it recommends OTC devices use a signal processing scheme that reduces gain as input level increases, and as a minimal standard, employs input compression and a volume control. In order to prevent long-term over-exposure to sound, the peak (or maximum) 2cc-coupler OSPL90 should not exceed 110 dB SPL, states the working group. It’s worthwhile to note that this exceeds the upper limits of some of the standards currently being employed in the EU.

For obvious safety reasons, the consensus paper recommends OTC products be limited only to instant-fit eartips (ie, custom earmold fabrication should be limited to licensed hearing care professionals). Due to the majority of Americans—including seniors—now using cell phones, the devices should use the ANSI Standard RF immunity rating system and meet the M2/T2 standard (if a T-coil is available), which is the current minimal standard for today’s hearing aids.

2) Out-of-the-box labeling with “Red Flag” warnings and a strong recommendation to consult with a licensed hearing care professional. Two other major contentious issues surrounding an OTC hearing device center on those consumers with life-threatening medical issues (eg, an acoustic neuroma) or the possibility that consumers  might be dissuaded from seeking professional assistance if their device does not work for them or give up if their unique hearing loss is not satisfactorily resolved.  Additionally, several hearing care professionals and organizations are concerned that an OTC device will be used for a child instead of providing them with the necessary care associated with pediatric hearing loss. With that in mind, the consensus statement recommends out-of-the-box labeling that states:

“This device is intended for use only by adults (minimum age 18) with mild-to-moderate hearing loss, who have difficulties hearing conversational speech. This device is not intended for use by children. Benefits from this device may vary from individual to individual. If you have any questions, concerns or need further assistance with regards to your ability to hear it is recommended that you consult with a hearing healthcare professional before purchasing this device.”

Concerning “red flag” conditions, the Working Group also recommends the following outside-the-box labeling:

Important notice for the prospective users: Hearing loss is a medical condition best addressed in consultation with a licensed hearing healthcare professional. If you experience any of the following conditions, do not purchase this product and consult a hearing care professional before proceeding:

 Visible deformities of the ear since birth or from injury

 Fluid, pus, or blood coming out of the ear within the previous three months

 Sudden, quickly worsening, or fluctuating hearing loss within the previous three months

 Dizziness or periodic vertigo associated with hearing loss

 Hearing loss in only one ear or a large difference in hearing between ears

 Ear wax build up or feeling that something is in the ear canal

 Pain or discomfort in the ear

 Tinnitus or ringing in one or both of your ears.

3) Inside-of-the-box labeling. In addition to the User Instructional Brochure, the consensus paper urges emphasizing that the device is not intended for children, that it should not be worn for more than 12 hours a day if the sound level causes discomfort, and provides numerous examples when to stop using the device and/or seek professional care from a licensed practitioner. Details regarding the technical data about the device (eg, Max OSPL90, HFA-FOG, Battery type, etc) should also be included inside the packaging.

4) Define new OTC category as “Self-fit OTC Hearing Devices” and use risk class requirements for safety and effectiveness. Confusion by consumers about the difference between a hearing aid and personal sound amplification product (PSAP) have been an ongoing concern, and the creation of an OTC device category threatens to exacerbate the problem. The consensus paper recommends defining the new category as “Self-Fit Over-the-Counter Hearing Devices” to clearly distinguish them from hearing aids and PSAPs. According to the Working Group, all device classification should be based on intended use, conditions for sale, and risk classification. Therefore, it follows that the new OTC devices be classified with traditional hearing aids as Class I and Class II devices and be required to undergo a first-time FDA premarket authorization (ie, 510(k) clearance). Those devices receiving 510(k) would then be applicable for premarket clearance exemptions.  

5) Adequate provisions for consumer protection and oversight by FTC. The reputation of hearing healthcare has suffered in the past due to unscrupulous companies, and the FDA and Federal Trade Commission (FTC) have provided strong federal guidance, along with the states, in protecting consumers. Currently, 32 states have return and refund policies for hearing aids, but the OTC Hearing Aid Act may pre-empt these protections. The Working Group’s recommendation is that FDA, in coordination with the FTC, establish strong consumer protection regulations, and strongly recommends that return and refund policies be defined for this new category. It also recommends that specific attention be called to marketing claims for this new category, and that FDA and FTC create a process to ensure that all product claims are substantiated by data, scientific evidence, and/or clinical studies.