Original article (in Slovenian) was published on 12/7/2024; Author: Nina Rozman
Otorhinolaryngologist Saba Battelino warns that ads for supposedly adaptive hearing aids can mislead people with poor hearing into buying the product instead of consulting a doctor. By doing so, they risk missing dangerous diseases for which hearing loss is a symptom.
“Introducing the PureSound Pulse hearing amplifier, the only amplifier on the market with new sound technology that adapts to the environment and the level of hearing loss,” reads an ad by the Polish company TWT Group, published in the print edition of Slovenske Novice on 29 June.
The ad claims that the hearing amplifier instantly amplifies relevant sounds by up to 147% and suppresses unwanted ones with a nanoprocessor that uses a special algorithm to detect sounds in all environments. It also claims the device will restore the audibility of human speech quickly and permanently, allowing people to hear the full range of sound frequencies.
Saba Battelino, a specialist in otorhinolaryngology and head of the Audiovestibulology Centre at the Clinic of Otorhinolaryngology and Cervicofacial Surgery, University Medical Centre Ljubljana, confirmed to Razkrinkavanje.si that doctors have “repeatedly designated similar ads as misleading and even harmful to persons with hearing loss”.
In their efforts to remove misleading and harmful advertisements, specialists have already turned to the Health Inspectorate and Market Inspectorate, which have always dismissed the complaints saying that sponsors of ads not registered in Slovenia are not subject to Slovenian law.
The otorhinolaryngologist explained that such ads can mislead people with hearing loss into buying the advertised device instead of visiting a doctor. By buying such a device, they risk overlooking a potentially dangerous disease of which poor hearing is the first symptom.
“Hearing loss is a symptom that requires a consultation and examination by a doctor. An otorhinolaryngologist can only prescribe a hearing aid to a hearing-impaired person if he or she determines that the person needs treatment.” Patients can then go to an authorised hearing aid vendor who will fit and deliver a hearing aid based on the doctor’s report and the hearing loss curve.
The Public Agency for Medicinal Products and Medical Devices (JAZMP) confirmed to Razkrinkavanje.si that they have initiated an inspection procedure in connection with the advertising of the “hearing amplifier”. They added that they were establishing the facts and circumstances before they decide whether to take action in accordance with their powers and legislation on medical devices.
They explained that the regulatory status of a medical device is governed by the EU member state in which the manufacturer or its authorised representative is incorporated. TWT Group does not have its registered office in Slovenia and is therefore not entered in the Slovenian Companies Register, they added.
The Health Insurance Institute (ZZZS) explained to Razkrinkavanje.si that TWT Group “is not a contractual partner for the supply of medical devices” and that “ZZZS does not or has never done business with them in any way”.
According to the Polish business register, the company is based in Warsaw and was registered on 16 January last year. The available data shows it registered for advertising, trade and postal services, business consultancy, and other unclassified business support activities.
Under the European Medical Devices Regulation, companies are prohibited from attributing functions and characteristics to a device in ads when such would give a false impression of a treatment, diagnosis, function or property that the product does not have.
The advert was designated as a scam by a hearing aid company which is a registered supplier of medical devices at the JAZMP. They warned that such sound amplifiers can damage hearing because they are not adapted to specific hearing needs. What is more, such devices do not have a warranty, service support or clear instructions on how to use them, so users risk making their condition worse if they do not see a specialist and receive a proper diagnosis.
According to the Code of Conduct of the Slovenian Advertising Chamber, advertising of medicines and medical devices must promote their rational use and present the products objectively, without exaggerating their properties. The Chamber explained that it could not yet comment on the specific ad since it is the subject of a complaint procedure before the Advertising Arbitration Tribunal.
The corporate communications department of Delo, the publisher of Slovenske Novice, explained to Razkrinkavanje.si that the PureSound Pulse hearing amplifier ad was published only once in this media outlet. “After receiving and before publishing the ad, we warned the client that, in accordance with Slovenian legislation, they as the advertiser are responsible for the truthfulness and accuracy of the advertised claims.”
They pointed out that some of the statements in the ad which were not in line with the Medical Devices Act were considered problematic and suggested that the client delete them. “Because the client insisted that all the statements highlighted were true and correct and they took responsibility for all the advertised content, which they confirmed to us in writing, we published the ad,” they explained.
They added that, in this specific case they had exercised all due diligence required of media by law. “However, in view of highlighted problems concerning the ad, the management of Delo has decided that we will no longer publish this ad in our outlets.”
The claim that “the PureSound Pulse hearing amplifier is the only hearing amplifier on the market with new sound technology that adapts to the environment and the level of hearing loss” is not true. Only medical devices prescribed based on a doctor’s opinion are tailored to the needs of individual patients.
