COLUMBUS, OH—Reacting to the growing prevalence of direct-to-consumer hearing aid sales, the Ohio House of Representatives is considering legislation that would ban the sale of hearing aids to any Ohio resident who has not received an in-person hearing evaluation at a location within the state.
Introduced in March by Rep. Rex Damschroder (R-Fremont), House Bill 109 requires that people who purchase hearing aid devices on the Internet must first have a consultation with a licensed hearing care professional. Damschroder said, “This bill is really all about consumer protection. Unfortunately, many hearing devices obtained online do not meet the specific needs of the individual buying these products.”
HB 109 is endorsed by two state agencies–the Board of Speech-Language Pathology and Audiology and the Ohio Hearing Aid Dealers and Fitters Licensing Board–and also by at least one professional organization, the Ohio Speech-Language-Hearing Association (OSLHA). OSLHA recently issued a statement, “Support HB 109: A Consumer Protection Solution to Internet Hearing Aid Sales.”
In it, the association notes that hearing loss is sometimes a symptom of a serious medical condition, which is likely to go undetected and untreated if a consumer orders hearing aids online without first seeing a professional trained to identify possible medical issues.
The association also warns that if a person is fitted with the wrong hearing aids or with unneeded amplification, it may result in permanent damage to the person’s hearing.
Moreover, it points out that any unethical practices of Internet hearing aid sellers are not subject to review or disciplinary sanctions by the state of Ohio.
The proposed law would set a $1000 fine for violations of its provisions.
TEEN TESTIFIES AT HEARING
On May 16, Tyler Bowes, a high school senior with hearing loss, testified before the Ohio House Health and Aging Committee. In advocating passage of the bill, he drew upon his personal experiences. Several health care professionals joined him in speaking in favor of the measure.
DOUBTS AND QUESTIONS
It is unclear how much, if any, effect passage of HB 109 would have. For one thing, some of the largest companies that sell hearing aids online already comply with the proposed rules.
For example, while consumers can buy hearing aids directly from Hearing Planet, qualified professional select and fit them, so the Ohio law would not apply to that company’s program.
That also appears to be the case with UnitedHealthcare’s hi HealthInnovations hearing aid program. When the program was unveiled in 2011, hi HealthInnovations directed consumers to take an online hearing test. The company then sent them hearing aids that were programmed on the basis of that test, which meant that the entire transaction could take place without a hearing professional being involved.
However, as reported on this blog, in March 2012 the Food and Drug Administration (FDA) sent a warning letter to hi HealthInnovations saying that by marketing the online hearing test without FDA’s approval, it was violating the Federal Food, Drug, and Cosmetic Act.
The company quickly dropped the online hearing test and now requires consumers to submit an audiogram before they can purchase hearing aids. That means that hi HealthInnovations customers are now seeing a professional before getting their hearing aids.
Many other Internet hearing aid companies would be subject to the Ohio law, at least in theory. However, nine other states have passed legislation similar to what Ohio is considering. Also, existing FDA regulations are intended to ensure that hearing aid patients see a health care professional. Yet, in the absence of effective enforcement of such measures, it appears that Internet companies are able to continue selling hearing aids directly to consumers, whether or not they have received any professional help with their hearing problems.
MEANWHILE, IN SOUTH AFRICA
PRETORIA, SOUTH AFRICA–Possibly efforts in South Africa will be more successful. There, the Speech, Language and Hearing Professional Board of the Health Professions Council of South Africa issued a public warning in April against purchasing hearing aids or amplifiers directly from retail pharmacies and other non-registered persons.
http://www.hpcsa.co.za/downloads/press_releases/presss_release_2013/hpcsa_med_rel_warn_ill_sale_hea_aid_cou_cau_per_dam_22_pril_2013.pdf
The board’s statement said, “Not only are these pharmacies acting in contravention of the law, but these amplifiers could cause irreversible hearing loss to normal hearing members of the public.”
The board added that it has received complaints about the sale of hearing aids to the public by unregistered people working at certain national pharmacies and retailers.
