10-31-2021, 11:37 PM
Today, the US Food and Drug Administration (FDA) published its proposed rules for a new category of over-the-counter (OTC) hearing aids in the Federal Register. Designed to make hearing aids more affordable and accessible for people with mild-to-moderate hearing loss, the new proposed regulations are more extensive than expected—essentially breaking hearing aids up into two categories for the purpose of labeling: “OTC hearing aids” and “prescription hearing aids” (professionally dispensed aids). The regulations are crafted to create a new OTC class of hearing aids that could be sold directly to consumers in stores or online without a medical exam or fitting by a hearing care professional (HCP). Mandated by the FDA Reauthorization Act of 2017 (FDARA), the FDA says it also wishes to increase competition in the market while ensuring the safety and effectiveness of both OTC and prescription hearing aids.
The 114-page rules document, “Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids,” covers most aspects related to OTC hearing aid manufacturing, electroacoustic requirements, packaging and labeling, returns, and conditions for sale. In an effort to promote more consistency in the regulations and enforcement of hearing aid manufacturing and distribution, the FDA is also proposing several important changes that would affect the industry and state-wide hearing aid dispensing. In fact, it appears that the FDA is proposing to remove professionally dispensed hearing aids from its restricted device category. It states:
This rulemaking also affects other existing regulations that apply to hearing aids. FDA has established device restrictions for hearing aids that include labeling requirements as well as conditions for sale. We are proposing to remove these device restrictions for hearing aids, and establish a new regulation for prescription hearing aid labeling. Further, FDA has by regulation granted or denied exemptions from Federal preemption for State requirements pertaining to hearing aids. The removal of the device restrictions on hearing aids, as well as certain provisions of FDARA, impact most of these previous exemption decisions, for example, by altering their scope. We are proposing to remove the regulations codifying these decisions and establish other regulations clarifying some of the effects of statutory preemption under FDARA.
In the document, FDA refers repeatedly to recommendations made by the President’s Council of Advisors for Science and Technology (PCAST) and the Committee on Accessible and Affordable Hearing Health Care for Adults, a part of the National Academies of Sciences and Medicine (NASEM). However, at least when it comes to the extremely important issue of output levels which largely determines the hearing loss severity range treatable by OTC devices, the Agency sided with positions advocated by the Consumer Technology Association (CTA) instead of those promulgated by the OTC Hearing Aid Consensus Statement published by AAA, ADA, IHS, and ASHA (for a summary, see Oct 2018 Hearing Review, pgs 8-9) and endorsed by the Hearing Industries Association (HIA). With up to a 120 dB SPL output limit proposed for the new OTC devices, a closed-fit OTC hearing aid could creep into the severe hearing loss range.
Additionally, FDA refers to the new device category as “OTC hearing aids” whereas it had been recommended by the consensus statement they be called “self-fit over-the-counter hearing devices” so as not to cause any further confusion among consumers.
OTC hearing aid manufacturers would be given a pass by FDA when it comes to product returns if the new regulations go unchanged; however, state or local requirements for returns would continue to apply provided they don’t conflict with the FDA’s final rulemaking. Additionally, the manufacturer would need to describe their return policy (or lack thereof) on the product packaging.
For a good deal of the other issues—ranging from product labeling to electroacoustic specifications— the new rules for OTC hearing aids hew fairly close to the consensus statement positions advocated by the professional organizations. At several places within the rules, there is emphasis that OTC hearing aids are intended for use by adults ages 18 and older with mild-to-moderate losses.
Importantly, the OTC Hearing Aid regulations, in accordance with the FDARA of 2017, would preempt any state or local requirements specifically related to hearing products that “would restrict or interfere with commercial activity involving OTC hearing aids, including any state or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access OTC hearing aids,” according to the document. In other words, non-professionals and professionals alike can dispense OTC hearing aid products; however, the regulations are not meant to interfere with or pre-empt state requirements regulating professional services of audiologists, hearing aid specialists, or speech pathologists.
Consolidating Hearing Device Categories
Over the years, FDA has created different regulations for the variety of hearing devices as technology and use-cases evolved. FDA would now like to re-align and categorize its hearing aid regulations by “sound-conduction mode.” It proposes combining wireless and non-wireless (“legacy”) hearing aids, as well as self-fit hearing aids (eg, Bose Self-fitting Hearing Aid), into an “air conduction hearing aid” class, including OTC hearing aids as a separate subset. It would also retain the separate classification regulation for bone-conduction devices. FDA says this realignment would not affect the device class or premarket notification exemption status (ie, 510k filing requirements) of any existing device. Additionally, for the sake of consistency, some special controls for wireless hearing aids would be removed and replaced by the proposed labeling requirements for both OTC and prescription hearing aids.
As shown above, FDA is calling for something of a “clean slate” when it comes to the agency’s previous decisions about state and local exemptions on conditions for sale of hearing aids. Over the past four decades, FDA has granted or denied hundreds of state exemptions pertaining to hearing aids, with some exemptions pre-empting others in confusing ways. It is proposing removal of these decisions and establishment of other regulations, along with a more transparent system that would better clarify the rules in each state for all stakeholders. (This is perhaps one of the most complicated pieces of the regulatory puzzle, and will be addressed in later articles.)
A Deeper Dive into Some Specifics in the Proposed OTC Regulations
The above withstanding, here are some of the high-points of the newly proposed OTC regulations:
Loudness limits. Perhaps the most important debate topic for OTC hearing aids revolves around safe volume levels for consumers. In the FDARA of 2017, Congress mandated that the new OTC classification be for mild-to-moderate hearing losses, typically defined from 20-55 dBHL. The proposed rule might be seen as very liberal in its allowance of output, with a maximum OSPL90 of 120 dB SPL for an OTC hearing aid that implements input-controlled compression and a user-adjustable device volume control (VC), and a 115 dB SPL for those that do not. “This is because a user adjustable volume control allows the user to reduce the output below the maximum, in effect, further reducing the device’s limit,” states the agency. “Input-controlled compression is an automatic function that dynamically reduces the output of frequency ranges based on the input. Both of these design features thus reduce the likelihood that a user will experience high acoustic outputs, at the device’s limit, at any given moment.”
However, these proposed 115-120 dB SPL limits substantially exceed those recommended by the OTC Hearing Aid Consensus Statement, and could push a closed-fit OTC hearing aid into the severe hearing loss category. In the consensus paper, the four national hearing care organizations recommended OTC devices to be intended only for mild-to-moderate hearing losses of 26-55 dB HL with a 110 dB max output (26 dB max HFA-FOG), while offering input compression and volume controls. In the July 2020 edition of Hearing Review, three audiologists from the hearing industry published data that showed how, based on the audiograms of over 28,000 adults, commercially available hearing aids programmed according to parameters typical of people with mild-to-moderate hearing loss yield output and gain levels well within the consensus-recommended limits of 110 dB SPL output and 25 dB gain.
The agency is proposing not to restrict loudness levels for OTC hearing aids based on gain because it believes the proposed maximum output limit, along with the other requirements, provides “reasonable assurance of safety and effectiveness without limiting the device gain also.” It points out that gain characteristics can depend on the implementation of the amplification circuit design (eg, linear vs WDRC), and wishes to allow for more technological innovations for the upcoming device class.
Electroacoustic requirements. The proposed regulations also include a subset of tests and specifications adopted from the ANSI/CTA-2051 voluntary standard for amplification devices. The FDA believes the following provide “reasonable assurance of safety and effectiveness, as well as set an objective baseline for device performance”:
Other OTC hearing aid design requirements. Other proposed design requirements to ensure proper physical fit and prevent user injury, include:
Consistent with existing regulations, FDA proposes that any reused or rebuilt hearing aid contain labeling both on the packaging, as well as a tag on the hearing aid itself, disclosing that fact.
Outside package labeling. Outside the package, the FDA is proposing for OTC hearing aids:
With regard to the red flags, the FDA is recommending that the duration of red flag symptoms for OTC hearing aid users be lengthened from the last 3 months to 6 months in order to provide greater consumer safety.
Inside-package labeling. Inside the OTC hearing aid packaging, the manufacturer should include:
Labeling on the OTC hearing aid. As proposed in the rules, each OTC hearing aid would have its serial number printed directly on the device and include battery orientation symbols, if applicable. It also needs to have a tag physically attached to the device stating it has been reused/rebuilt if that is the case (in addition to the outside packaging).
Quality system controls and good manufacturing practices. This is also an area that the agency is soliciting more information about.
Proposed Changes for Professionally Fit Hearing Aids
As noted above, the FDA is also proposing the repeal and changes to certain conditions for sale of hearing aids as “restricted devices” prescribed by HCPs. Another important change is eliminating the requirement of a medical evaluation prior to obtaining professionally dispensed (or what the FDA is calling “prescription”) hearing aids, broadly referred to in our field as the “medical waiver”. Essentially, the requirement of a medical waiver is now up to state/local and professional licensing boards. While the FDA had announced in December 2016 that it would no longer enforce the medical waiver requirement, this would more firmly codify its position, placing it more in line with the proposed OTC regulations.
Likewise, to more closely match safety measures with the new OTC regulations, the proposed rules would require professionally dispensed hearing aid labeling to include warnings about underlying pathological conditions, use in people younger than 18 without a medical evaluation, and potential injury from high outputs. The proposed regulations also call for the disclosure by manufacturers of certain technical specifications (re: ANSI/ASAS3.22-2014) necessary for the appropriate selection and fitting of the device by the professional.
Timeline to the Finalized Rules
A 90-day comment period will be in effect, and this is typically followed by a 180-day period during which FDA reviews comments received, makes changes to its proposed rules, writes a preamble, and obtains the necessary sign-offs. Once finalized, the rule would be effective 60 days after publication in the Federal Register. That means, barring an accelerated timeline, it will be at least another 11 months before the final rules go into effect, pushing OTC into about September 2022.
You can submit comments electronically at the FDA electronic filing system at https://www.regulations.gov. There are also ways to submit the comments with confidential information, and these are detailed in the proposed rules document.
About the author: Karl Strom is editor of The Hearing Review and has been reporting on hearing healthcare issues for over 25 years.
The 114-page rules document, “Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids,” covers most aspects related to OTC hearing aid manufacturing, electroacoustic requirements, packaging and labeling, returns, and conditions for sale. In an effort to promote more consistency in the regulations and enforcement of hearing aid manufacturing and distribution, the FDA is also proposing several important changes that would affect the industry and state-wide hearing aid dispensing. In fact, it appears that the FDA is proposing to remove professionally dispensed hearing aids from its restricted device category. It states:
This rulemaking also affects other existing regulations that apply to hearing aids. FDA has established device restrictions for hearing aids that include labeling requirements as well as conditions for sale. We are proposing to remove these device restrictions for hearing aids, and establish a new regulation for prescription hearing aid labeling. Further, FDA has by regulation granted or denied exemptions from Federal preemption for State requirements pertaining to hearing aids. The removal of the device restrictions on hearing aids, as well as certain provisions of FDARA, impact most of these previous exemption decisions, for example, by altering their scope. We are proposing to remove the regulations codifying these decisions and establish other regulations clarifying some of the effects of statutory preemption under FDARA.
In the document, FDA refers repeatedly to recommendations made by the President’s Council of Advisors for Science and Technology (PCAST) and the Committee on Accessible and Affordable Hearing Health Care for Adults, a part of the National Academies of Sciences and Medicine (NASEM). However, at least when it comes to the extremely important issue of output levels which largely determines the hearing loss severity range treatable by OTC devices, the Agency sided with positions advocated by the Consumer Technology Association (CTA) instead of those promulgated by the OTC Hearing Aid Consensus Statement published by AAA, ADA, IHS, and ASHA (for a summary, see Oct 2018 Hearing Review, pgs 8-9) and endorsed by the Hearing Industries Association (HIA). With up to a 120 dB SPL output limit proposed for the new OTC devices, a closed-fit OTC hearing aid could creep into the severe hearing loss range.
Additionally, FDA refers to the new device category as “OTC hearing aids” whereas it had been recommended by the consensus statement they be called “self-fit over-the-counter hearing devices” so as not to cause any further confusion among consumers.
OTC hearing aid manufacturers would be given a pass by FDA when it comes to product returns if the new regulations go unchanged; however, state or local requirements for returns would continue to apply provided they don’t conflict with the FDA’s final rulemaking. Additionally, the manufacturer would need to describe their return policy (or lack thereof) on the product packaging.
For a good deal of the other issues—ranging from product labeling to electroacoustic specifications— the new rules for OTC hearing aids hew fairly close to the consensus statement positions advocated by the professional organizations. At several places within the rules, there is emphasis that OTC hearing aids are intended for use by adults ages 18 and older with mild-to-moderate losses.
Importantly, the OTC Hearing Aid regulations, in accordance with the FDARA of 2017, would preempt any state or local requirements specifically related to hearing products that “would restrict or interfere with commercial activity involving OTC hearing aids, including any state or local requirement for the supervision, prescription, or other order, involvement, or intervention of a licensed person for consumers to access OTC hearing aids,” according to the document. In other words, non-professionals and professionals alike can dispense OTC hearing aid products; however, the regulations are not meant to interfere with or pre-empt state requirements regulating professional services of audiologists, hearing aid specialists, or speech pathologists.
Consolidating Hearing Device Categories
Over the years, FDA has created different regulations for the variety of hearing devices as technology and use-cases evolved. FDA would now like to re-align and categorize its hearing aid regulations by “sound-conduction mode.” It proposes combining wireless and non-wireless (“legacy”) hearing aids, as well as self-fit hearing aids (eg, Bose Self-fitting Hearing Aid), into an “air conduction hearing aid” class, including OTC hearing aids as a separate subset. It would also retain the separate classification regulation for bone-conduction devices. FDA says this realignment would not affect the device class or premarket notification exemption status (ie, 510k filing requirements) of any existing device. Additionally, for the sake of consistency, some special controls for wireless hearing aids would be removed and replaced by the proposed labeling requirements for both OTC and prescription hearing aids.
As shown above, FDA is calling for something of a “clean slate” when it comes to the agency’s previous decisions about state and local exemptions on conditions for sale of hearing aids. Over the past four decades, FDA has granted or denied hundreds of state exemptions pertaining to hearing aids, with some exemptions pre-empting others in confusing ways. It is proposing removal of these decisions and establishment of other regulations, along with a more transparent system that would better clarify the rules in each state for all stakeholders. (This is perhaps one of the most complicated pieces of the regulatory puzzle, and will be addressed in later articles.)
A Deeper Dive into Some Specifics in the Proposed OTC Regulations
The above withstanding, here are some of the high-points of the newly proposed OTC regulations:
Loudness limits. Perhaps the most important debate topic for OTC hearing aids revolves around safe volume levels for consumers. In the FDARA of 2017, Congress mandated that the new OTC classification be for mild-to-moderate hearing losses, typically defined from 20-55 dBHL. The proposed rule might be seen as very liberal in its allowance of output, with a maximum OSPL90 of 120 dB SPL for an OTC hearing aid that implements input-controlled compression and a user-adjustable device volume control (VC), and a 115 dB SPL for those that do not. “This is because a user adjustable volume control allows the user to reduce the output below the maximum, in effect, further reducing the device’s limit,” states the agency. “Input-controlled compression is an automatic function that dynamically reduces the output of frequency ranges based on the input. Both of these design features thus reduce the likelihood that a user will experience high acoustic outputs, at the device’s limit, at any given moment.”
However, these proposed 115-120 dB SPL limits substantially exceed those recommended by the OTC Hearing Aid Consensus Statement, and could push a closed-fit OTC hearing aid into the severe hearing loss category. In the consensus paper, the four national hearing care organizations recommended OTC devices to be intended only for mild-to-moderate hearing losses of 26-55 dB HL with a 110 dB max output (26 dB max HFA-FOG), while offering input compression and volume controls. In the July 2020 edition of Hearing Review, three audiologists from the hearing industry published data that showed how, based on the audiograms of over 28,000 adults, commercially available hearing aids programmed according to parameters typical of people with mild-to-moderate hearing loss yield output and gain levels well within the consensus-recommended limits of 110 dB SPL output and 25 dB gain.
The agency is proposing not to restrict loudness levels for OTC hearing aids based on gain because it believes the proposed maximum output limit, along with the other requirements, provides “reasonable assurance of safety and effectiveness without limiting the device gain also.” It points out that gain characteristics can depend on the implementation of the amplification circuit design (eg, linear vs WDRC), and wishes to allow for more technological innovations for the upcoming device class.
Electroacoustic requirements. The proposed regulations also include a subset of tests and specifications adopted from the ANSI/CTA-2051 voluntary standard for amplification devices. The FDA believes the following provide “reasonable assurance of safety and effectiveness, as well as set an objective baseline for device performance”:
- Distortion control limits;
- Self-generated noise limits;
- Latency limit;
- Frequency response bandwidth, and
- Frequency response smoothness limits.
Other OTC hearing aid design requirements. Other proposed design requirements to ensure proper physical fit and prevent user injury, include:
- Maximum insertion depth;
- Eartips made from atraumatic materials;
- Proper physical fit, and
- Tools, tests, or software allowing the lay user to control the device and customize it to the user’s hearing needs.
Consistent with existing regulations, FDA proposes that any reused or rebuilt hearing aid contain labeling both on the packaging, as well as a tag on the hearing aid itself, disclosing that fact.
Outside package labeling. Outside the package, the FDA is proposing for OTC hearing aids:
- A conspicuous warning that the device is not for users younger than 18 years old;
- Symptoms of perceived mild-to-moderate hearing loss (with examples);
- Considerations for seeking a consultation with a hearing healthcare professional, and
- Red flag conditions.
With regard to the red flags, the FDA is recommending that the duration of red flag symptoms for OTC hearing aid users be lengthened from the last 3 months to 6 months in order to provide greater consumer safety.
Inside-package labeling. Inside the OTC hearing aid packaging, the manufacturer should include:
- Warnings, cautions, and notes, including a conspicuous statement warning against the use of the OTC hearing aid in people younger than 18 years old, as well as a warning regarding “red flag” medical conditions to prompt consumers to consult with a licensed physician and a note about how to report adverse events to FDA;
- Illustrations about the controls, user adjustments, and the battery compartment;
- A description of any accessory that accompanies the OTC hearing aid;
- Adequate directions for use of the product, including details for sizing and inserting the eartip as well as the tools, tests, or software that allow the user to control and customize the OTC hearing aid to the user’s hearing needs (eg, to self-select, self-fit, and self-check the performance of the device);
- Technical specifications to allow users, prospective users, and others to evaluate and compare the performance of OTC hearing aids;
- Description of commonly occurring, avoidable events that could adversely affect or damage the OTC hearing aid;
- Identification of known physiological side effects associated with using the OTC hearing aid that may warrant consultation with a physician, including but not limited to skin irritation and accelerated build-up of ear wax (cerumen accumulation);
- Information on repair services; and
- Information from clinical and non-clinical studies pertaining to the product.
Labeling on the OTC hearing aid. As proposed in the rules, each OTC hearing aid would have its serial number printed directly on the device and include battery orientation symbols, if applicable. It also needs to have a tag physically attached to the device stating it has been reused/rebuilt if that is the case (in addition to the outside packaging).
Quality system controls and good manufacturing practices. This is also an area that the agency is soliciting more information about.
Proposed Changes for Professionally Fit Hearing Aids
As noted above, the FDA is also proposing the repeal and changes to certain conditions for sale of hearing aids as “restricted devices” prescribed by HCPs. Another important change is eliminating the requirement of a medical evaluation prior to obtaining professionally dispensed (or what the FDA is calling “prescription”) hearing aids, broadly referred to in our field as the “medical waiver”. Essentially, the requirement of a medical waiver is now up to state/local and professional licensing boards. While the FDA had announced in December 2016 that it would no longer enforce the medical waiver requirement, this would more firmly codify its position, placing it more in line with the proposed OTC regulations.
Likewise, to more closely match safety measures with the new OTC regulations, the proposed rules would require professionally dispensed hearing aid labeling to include warnings about underlying pathological conditions, use in people younger than 18 without a medical evaluation, and potential injury from high outputs. The proposed regulations also call for the disclosure by manufacturers of certain technical specifications (re: ANSI/ASAS3.22-2014) necessary for the appropriate selection and fitting of the device by the professional.
Timeline to the Finalized Rules
A 90-day comment period will be in effect, and this is typically followed by a 180-day period during which FDA reviews comments received, makes changes to its proposed rules, writes a preamble, and obtains the necessary sign-offs. Once finalized, the rule would be effective 60 days after publication in the Federal Register. That means, barring an accelerated timeline, it will be at least another 11 months before the final rules go into effect, pushing OTC into about September 2022.
You can submit comments electronically at the FDA electronic filing system at https://www.regulations.gov. There are also ways to submit the comments with confidential information, and these are detailed in the proposed rules document.
About the author: Karl Strom is editor of The Hearing Review and has been reporting on hearing healthcare issues for over 25 years.