On February 13, 2004 the Food and Drug Administration (FDA) denied two Citizen Petitions that, if approved, would have allowed over-the-counter sale of hearing aids. IHS and other industry associations forcefully opposed the petitions and sent letters of protest to FDA. These letters were cited by FDA as having contributed to their decision to deny the petitions.
IHS President W. F. Samuel Hopmeier, BC-HIS, is proud of the effectiveness of IHS’s action on this issue. “This is a wonderful accomplishment for the benefit of the hearing impaired and expresses IHS’s leadership as a hearing healthcare professional organization,” he said. “Thank you to our Washington support team and the IHS Board of Governors and staff for a job well done.”
The petitions were submitted to FDA in August 2003 by Gail Gudmundsen, AuD, and Mead Killion, PhD, president and founder of Etymotic Research (where Gudmundsen is also employed). Gudmundsen’s petition requested that FDA revise the federal hearing aid regulations so that adults would not be required to have a medical screening (or sign a waiver) before buying hearing aids. Killion’s petition asked FDA to create a new category of non-custom hearing aids that, like non-prescription reading glasses, adults could purchase in retail establishments without restrictions.
The IHS Board of Governors took a decisive stand against the petitions, activating its regulatory counsels to communicate their position to FDA both orally and via the filing of formal written comments. Excerpts from the IHS letter of opposition follow. (To read the letter in its entirety, go to the IHS Website at ihsinfo.org.)
The International Hearing Society (IHS) submits the following comments in strong opposition to the Citizen Petitions submitted in August 2003 by two individual audiologists, Mead Killion, PhD, and Gail Gudmundsen, AuD. IHS represents the majority of licensed and certified hearing instrument specialists and other dispensers of hearing aids in the United States and Canada.
These petitions request that FDA withdraw, or substantially revise, its restricted device regulations for hearing aids. Proposed changes could have the effect of allowing the sale of these Class I medical devices over-the-counter (OTC) without the need for supervision by physicians or other state licensed hearing health professionals. The primary rationale for this request is an expressed belief that the cost of these instruments would be reduced and access increased. The petitioners argue further that such changes in FDA regulations would expand utilization of hearing aids by the estimated 28 million Americans who are hearing impaired. IHS believes the proposed changes would not expand the utilization of hearing aids. We strongly oppose the petitions. We request FDA-CDRH to deny these petitions for the reasons explained in greater detail below.
IHS unequivocally supports the goal of encouraging more Americans to successfully use hearing devices to treat various forms of hearing loss. That is the driving mission of our association. At the same time, IHS and its members have worked together with FDA for over 30 years to insure that patients with hearing loss are properly screened, tested and, if needed, fitted with the appropriate device from which they could derive the maximum benefit. It is appealing to simplify the regulatory system. IHS has previously offered numerous proposals to FDA to do so.
The petitioners propose to place these devices on the shelves of local pharmacies and grocery stores next to the supply of reading glasses and aspirin. However, such a proposal is deceptive, simplistic and would jeopardize the public health for reasons stated below. As discussed below, our first-hand experience in testing and fitting hearing aids indicates the following: (1) each device is dramatically different, especially now with digital v. analog technology; (2) users have very different needs; (3) a variety of cheaper listening devices is already available direct-to-consumer (DTC); (4) these DTC and mail-order devices are returned in greater percentages than custom-fit devices; (5) users require training, counseling and patience to adapt properly to amplified sound; (6) market data have shown that once a cheaper listening type device is selected and discarded by a consumer, they generally do not upgrade to more advanced technology; (7) the supervision of a trained and licensed hearing health professional is important for safe use to screen for treatable medical conditions; test for extent and cause of hearing loss; and to select, fit, adjust and train the user with the appropriate device in order to achieve the best possible clinical result.
FDA spent much of the last ten years examining methods to standardize and improve testing protocols to determine candidacy for hearing amplification devices. FDA also advocated eliminating the medical and waiver requirement contained in 801.421 because of a concern that it was being used too often. FDA has consistently stated that hearing aids should only be sold and used following a comprehensive hearing examination by a physician, preferably one specializing in diseases of the ear. IHS has worked tirelessly with the American Academy of Otolaryngology—Head and Neck Surgery (AAO-HNS). The two organizations have developed a screening questionnaire and checklist used by hearing health professionals to evaluate potential treatable medical conditions and make the proper medical referrals.
It would be totally inconsistent, and somewhat hypocritical, for FDA to reverse course 180 degrees and consider OTC sales. Such action would be analogous to legalizing drugs because you can’t control their use. There is no practical method in the current OTC marketplace to insure that trained professionals evaluate the use by purchasers of these products. Likewise, if the Agency still believes, as we do, that each member of the hearing health team performs an important public health function, OTC status for hearing aids is inappropriate.
In addition, the petitioner, or commenters, must furnish detailed and specific clinical evidence to demonstrate that professional supervision is not needed to use these devices properly and safely. We do not believe this evidence exists. Further, we believe that the minimal evidence cited by the petitioners, or commenters, favoring the petitions actually supports rejection of the petitions by substantiating the efficient functioning of the current regulations (e.g., May 1999, National Council on the Aging report, p. 2, which concluded that those who use hearing aids have improved mental health, better relationships, greater independence and security, etc.).
Further, a significant body of state licensing laws would be rendered moot should FDA take the actions advocated in the petitions. Indeed, virtually every state has laws governing both the licensing of hearing health professionals and the conditions for sale of hearing devices. Adopting the proposals in the Citizen Petitions would unnecessarily confuse the hearing impaired public and wreak havoc on state hearing healthcare delivery systems.
In summary, the community of hearing instrument specialists supports the current system. Hearing impaired consumers have a full range of choices, but are encouraged to see a physician before the purchase and to seek out medical evaluation if red flag symptoms appear. It is an old and overused adage in Washington, DC that “if it ain’t broke, don’t fix it.” Here, any proposal that would move in the direction of switching hearing aids from Rx to OTC could have a significant “ripple effect.” That action could discourage medical care and reduce or eliminate essential services rendered by licensed hearing health professionals. These services are necessary in order to protect consumers, to successfully evaluate need and to select and use the appropriate device.
Accordingly, IHS strongly urges that the aforementioned Citizen Petitions be rejected. IHS further urges that, in order to protect the hearing impaired public, FDA take regulatory action against false and misleading claims and mail-order and Internet sales. Proper testing and fitting by experienced professionals is required to protect all consumers, regardless of where they purchase their device. In the interest of consumer protection and consistency, FDA should enjoin these misleading promotional practices or seize the products. Despite the best efforts of numerous state attorneys general who entered into two separate Assurances of Voluntary Compliance with purveyors of certain mail order amplification devices, such misleading promotional practices persist, to the detriment of the hearing impaired public.
IHS Washington counsel also submitted a letter of opposition to FDA on behalf of America’s Hearing Healthcare Team (AHHT). AHHT is a public awareness initiative to educate consumers about professional help available for the hearing impaired. It is a joint collaboration between IHS and AAO-HNS. (The AHHT letter is also posted on the IHS Website.)
The FDA, in letters to Gudmundsen and Killion dated February 13, 2004, explained their reasons for denying the petitions. The following is excerpted from those letters. (The complete text of both can be found on the IHS Website.)
FDA is concerned that if prospective purchasers of hearing aids are not examined by a physician prior to purchasing and using the hearing aid, “red flag” ear conditions will go unrecognized and unevaluated. Red flag ear conditions are signs, symptoms or audiometric findings that a licensed physician must evaluate to determine whether a person experiencing hearing impairment is an appropriate candidate for a hearing aid, or whether his impairments may be medically or surgically treated. Examples of red flag ear conditions include: visible congenital or traumatic deformity of the ear; history of active drainage or bleeding from the ear within the previous six months; sudden or rapidly progressive hearing loss in either ear within the previous six months; air-bone gap of 15 decibels or greater at 500 Hz, 1,000Hz and 2,000Hz; asymmetric hearing loss; acute or chronic dizziness; visible evidence of excessive ear wax (cerumen) or a foreign body in the ear canal; and ongoing pain or discomfort in the ear.
Several of these red flag conditions cannot be diagnosed by the patient, and instead require physical examination of audiometric studies. Without appropriate screening for red flag conditions by a licensed physician, persons with hearing loss may purchase hearing aids to remedy their problems and may even experience some relief, while continuing to have serious medical conditions that should be properly diagnosed and treated. In some cases, this lack of, or at best delayed, diagnosis can lead to irreparable damage, further deterioration of hearing or increased risks of surgery for the hearing aid user.
Older adults are most likely to suffer as a result of your proposed elimination of the medical examination and waiver requirements. A recent study by the Journal of the American Medical Association (JAMA) indicates that hearing loss is the third most prevalent chronic condition in older adults in the United States, after hypertension and arthritis. The authors note that while most hearing loss in the elderly is sensorineural and due to presbycusis, up to 30% of these patients may have cerumen impaction and chronic otitis media that can be treated by the primary care physician. They further conclude that prompt recognition of potentially reversible causes of hearing loss is important to maximize the possibility of functional recovery.
FDA believes that elimination of the existing medical evaluation and waiver requirements may result in significant delays in the diagnosis and management of medically and surgically treatable causes of hearing loss. Delay in diagnosis and treatment of some of these conditions (e.g., cholesteatomas, autoimmune sensorineural hearing loss, tumors, ototoxicity and infections) may lead to further, irreversible loss of hearing and other adverse health consequences.
[In conclusion] FDA continues to believe that the safe and effective use of hearing aids depends on the collateral measure of a medical examination to ensure that a hearing aid, rather than medical or surgical treatment, is the appropriate solution for a particular person’s hearing impairment. If a patient over the age of 18 is unable or unwilling to seek a medical examination, after being advised that doing so is not in his or her best interest, that patient may utilize the waiver provision.
Robin Clowers, BC-HIS, IHS executive director, notes that the FDA rejection letters contain many of the points IHS has been putting forth for years. “It’s nice to see the government not only agreeing with our position, which was to issue a firm denial to each of the petitions, but also to understand that they (FDA) have actually heard many of the same arguments we have made over the past decade,” she said. THP
