Hearing aids and personal sound amplifiers

• Regulation (EU) 2017/745 — Medical Devices
• Directive 2014/53/EU where wireless
• Regulation (EU) 2016/679 for the companion app

Who has to appoint one

Manufacturers outside the Union placing hearing devices on the EU market. A hearing aid intended to compensate for a hearing impairment is a medical device, normally Class IIa. A personal sound amplification product marketed for situational listening without a medical purpose is a consumer product, but the marketing must genuinely support that.

Thresholds and exemptions

None. Classification depends entirely on intended purpose, and describing a device as an amplifier while advertising it to people with hearing loss will be treated as an unregistered medical device.

What must appear on the label

For devices: CE marking with the notified body number, manufacturer and EC REP details, UDI, serial number and the instructions for use. For consumer amplifiers: manufacturer and EU responsible person details, output limits and hearing safety warnings.

Marketplace fields

Marketplaces and app stores remove listings whose descriptions make hearing-loss claims without a device registration, and this category was the subject of coordinated action after the growth of direct-to-consumer sales.

Documentation you must hold

MDR technical documentation, clinical evaluation, risk management and post-market surveillance for devices, plus EUDAMED registration and the Article 11 mandate. For consumer amplifiers, the technical file, output measurement and the radio documentation.

Standards and testing

IEC 60118 series for hearing aid performance, IEC 60601 electrical safety for medical electrical equipment, biocompatibility for ear-contacting materials, and maximum output measurement to demonstrate hearing safety.

Language requirements

Instructions for use in the language required by each member state, which for medical devices is mandatory even where the user is a professional.

When it applies

Registration and certification before placing on the market. There is no European equivalent of the US over-the-counter hearing aid category, so US market authorisation does not transfer.

How long records are kept

Ten years under the MDR, fifteen for implantable devices.

What happens if you do not comply

Withdrawal and prohibition of sale, and for unregistered medical devices the finding is far more serious than a labelling defect. The Article 11 representative shares liability for defective devices.

Who enforces it

Medical device competent authorities, market surveillance authorities and radio regulators.

Where the boundary lies

The MDR route requires a notified body and an authorised representative that accepts joint liability, which is why we do not take that role. Pure consumer amplifiers remain feasible, but only where the marketing avoids any medical purpose.

Questions we are asked

Is an OTC hearing aid legal in the EU?

There is no OTC category in EU law. A device intended to compensate for hearing impairment is a medical device whatever the sales channel.

Can earbuds with a hearing mode be sold as consumer electronics?

Only if the intended purpose is not medical. Once the feature is marketed as helping hearing loss, the MDR applies.