Hello again Health777,
The Food and Drug Administration (FDA) does not permit the sale of
over-the-counter (OTC) hearing aids in drug stores and other retail
outlets.
FDA regulations state that a hearing aid cannot be sold unless the
buyer first receives a medical evaluation from a licensed physician. A
purchaser over the age of 18 can, however, sign a written waiver of
this requirement, but the dispenser must inform the purchaser that the
waiver is not in his or her best interest and must not in any way
encourage the purchaser to exercise the waiver.
?The U.S. hearing aid industry adheres to comprehensive federal
regulations governing both hearing aids and hearing aid sales
practices.
The U.S. Food and Drug Administration (FDA) enforce regulations that
deal specifically with the manufacture and sale of hearing aids
because these products are recognized as medical devices.?
?The most notable federal regulation is the rule requires that prior
to the sale of a hearing aid, the practitioner advise the patient that
it is in their best health interest to see a physician, preferably one
specializing in diseases of the ear, before purchasing a hearing aid.
The rule requires that a person obtain a medical evaluation of hearing
loss within six months prior to obtaining a hearing aid or sign a
waiver. The waiver provision is included to protect individual rights
and freedom of choice. The FDA pointed out that medical evaluation by
a physician is necessary in determining the cause of, and the
pathology associated with, the patient's hearing loss.?
?A patient age 18 or older can sign a waiver for a medical
examination, but dispensers must advise the patient that waiving the
examination is not in the patient's best health interest.?
?All practitioners engaged in the fitting and dispensing of hearing
aids must comply with all licensing requirements existing in the state
of their individual practice.?
IHS: Regulatory Standards
http://ihsinfo.org/IhsV2/About_Us/050_Regulatory_Standards.cfm
Citizen Petitions have been made for Over-the-Counter Hearing Aids.
Download here:
http://www.fda.gov/ohrms/dockets/dailys/03/Aug03/081203/03p-0362-cp00001-vol1.pdf
FDA Rejects Citizen Petitions for Over-the-Counter Hearing Aids
?The U.S. Food and Drug Administration (FDA) has rejected two citizen
petitions that would eliminate the need for a medical evaluation or
waiver prior to hearing aid purchase and create a class of
over-the-counter (OTC) hearing aids. The petitions generated intense
debate and strong opposition among hearing health professionals.?
Read more here:
http://www.asha.org/about/publications/leader-online/archives/2004/040427/040427b.htm
The Food and Drug Administration (FDA) has denied two citizen's
petitions that, if approved, would have opened the door to the
over-the-counter (OTC) sale of certain hearing aids in drug stores and
other retail outlets.
http://www.findarticles.com/p/articles/mi_hb3496/is_200403/ai_n8287141
?Today, two types of licensed specialists are the main vendors of
hearing aids. State-licensed hearing-aid specialists need only a
high-school education but have to pass tests proving their competence
to administer hearing exams, fit devices and recognize underlying
physical problems. Audiologists must have at least a master's degree,
though they generally aren't medical doctors. After the FDA rule went
into effect, audiologists changed their professional code of ethics
and jumped into the business of selling hearing aids.?
?Some consumers are buying devices over the Internet or via mail
order, bypassing doctors and specialists. Those sales have grown 83%
since 1997, to 3.5% of all hearing-aid sales, according to the Knowles
Electronics study. However, the quality of those devices varies
greatly, and some of the purveyors operate in a legally gray area,
since some states prohibit mail-order sales. Most, but not all,
include a waiver and the warning signs on their Internet site or
mail-order forms.?
http://www.rasmusen.org/g406/hearing.aids.wsj.htm
What states do not allow hearing aids to be bought through the mail?
A. At this time Colorado, Missouri, and Texas restrict sales of mail
order hearing aids.
http://www.westonbenefits.com/hearingfaq.html
http://www.allcara.com/faq2.asp
Hearing aids have been expensive and hard to get since 1977, when the
U.S. Food and Drug Administration (FDA) enacted its Hearing Aid Rule.
The rule required that consumers see a physician before buying a
hearing aid.
?The rule also created an exception: Adults could bypass a doctor if
they signed a waiver acknowledging the dangers of skipping a medical
evaluation.?
?
?But the situations is changing rapidly. Cheaper hearing aids are
suddenly easy to find, thanks to the Internet and mail-order catalogs.
Mail-order sales alone jumped over 90% between 1997 and 2000, the most
recent data available.
More and more companies are developing ways to sidestep the physician
process and sell directly to the consumer. Waivers are one option; one
Web-based outlet, Hearing Help Express, requires customers to sign a
waiver before the product can be shipped.?
?Another option is to market the product differently; Crystal Care
International says its Crystal Ear product is an "assisted-listening
device," not a hearing aid, and is therefore not obligated to follow
FDA standards.?
Read the full text of this article here:
http://www.consumeraffairs.com/health/hearing/hearing_aids_01.html
Further reading:
Dr. Ross on Hearing Loss and Over-the-Counter (OTC) Hearing Aids
http://www.hearingresearch.org/Dr.Ross/OTChearingaids.htm
Internet Hearing Aids: Here We Go Again...
http://www.healthyhearing.com/library/article_content.asp?article_id=192
IHS Opposition to Citizens Petitions
https://www.ihsinfo.org/IhsV2/News_Info/070_IHS_Opposition_to_Citizens_Petitions.cfm
The Noisy Debate Over Hearing Aids: Why So Expensive?
http://webreprints.djreprints.com/1257230721151.html
Search terms used:
FDA regulations hearing aids
Hearing aid sales medical evaluation
Over the counter hearing aids
OTC hearing aids
I hope the information provided is helpful.
Best regards,
Bobbie7 |
Request for Answer Clarification by
health777-ga
on
16 Jun 2006 11:45 PDT
The question was: What states do/don't collude with doctors and
audiologists, to prevent
low prices by prohibiting the over the counter sale of hearing aids?
In your research findings it says: ?Most states require that anyone
selling such device must be a professional who is licensed by the
State? But, I have not found your list indicating the States that do
not require a professional, who is licensed, to sell hearing aids.
A summary of your research indicates that:
1. Hearing aids cost over 20 times what they would cost, in over the
counter sales, because of State, Federal, Doctor, and Audiologist
collusion. Your research indicates that because the average hearing
aid cost $2,200.00 instead of the $100.00, they could cost, up to 80%
of the people who need hearing aids do not buy them. Going without
hearing aids creates a new pathology. Without hearing aids, these
persons gradually withdraw from active society, make mistakes in the
workplace or in social and family situations, and annoy their
companions, who must always raise their voices when speaking to them.
2. Federal regulation requires that prior to the sale of a hearing
aid, the practitioner advise the patient that it is in their best
health interest to see a physician, preferably one specializing in
diseases of the ear, before purchasing a hearing aid. This rule
requires that a person obtain a medical evaluation of hearing loss
within six months prior to obtaining a hearing aid or sign a waiver.
The waiver provision is included to protect individual rights and
freedom of choice.
3. A Hearing Aid Help line is at 1.800.521.5247
4. A study comparing a two-channel programmable analog hearing aid,
two of the latest-technology digital aids, and the $40.00 disposable
Songbird hearing aid indicated that the Songbird aid compared
favorably on every measure with the more expensive aids. OTC hearing
aid type devices are available from Radio Shack, magazines, catalogs,
newspaper ads, mail order and the Internet. sporting goods stores and
specialty catalogs.
5. Stores sell "listening devices" for people with normal hearing that
differ little from hearing aids. Sporting-goods stores sell ear
devices for hunters that muffle the sound of gunshots but also amplify
quiet sounds, these devices work for people who have trouble hearing.
Prices vary from $5.95 and up, for listening devices.
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Clarification of Answer by
bobbie7-ga
on
16 Jun 2006 13:27 PDT
All states except Massachusetts regulate hearing aid dispensers.
" B&P Code § 3351 exempts from licensure those engaged in the practice
for a governmental agency, private clinic, institution of higher
education, or a public nonprofit organization. Licensed physicians
and surgeons, audiologists, and individuals supervised by audiologists
who do not directly or indirectly engage in the sale of hearing aids
are also exempted from the licensing act (§ 3351.3).
There is a significant amount of regulatory overlap for hearing aid
dispensers. Approximately 40% of the 1,457 licensed hearing aid
dispensers are also licensed as audiologists by the Speech-Language
Pathology and Audiology Board (there are 1,238 audiologists).
Dispensers perform only those hearing tests required for the purpose
of fitting and selling hearing aids, and are prohibited from
conducting diagnostic testing."
http://www.sen.ca.gov/ftp/SEN/COMMITTEE/JOINT/SUNSET_REVIEW/_home/had_1998.doc
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