Hearing Aids in Israel and Abroad: What Differs

United States: over-the-counter (OTC) hearing aids

The FDA created an over-the-counter category. According to NIDCD the final rule was issued in August 2022; according to the FDA it took effect on 17 October 2022.

• These devices are for people aged 18 and over (FDA).
• They are for hearing loss that the person perceives as mild to moderate (FDA, NIDCD).
• They can be bought without a medical exam, a prescription or a fitting by an audiologist (FDA).
• They are not intended for severe or profound loss (FDA).

The US also has prescription hearing aids: according to the FDA, any hearing aid that does not meet the OTC requirements. They go through a licensed hearing professional who programs them. The FDA notes that personal sound amplification products (PSAPs) are not medical devices like hearing aids, and that the OTC rules do not require manufacturers to provide a warranty, so check the return or warranty period.

Earbuds with hearing-aid software

On 12 September 2024 the FDA authorized software called the Hearing Aid Feature, the first over-the-counter hearing-aid software. It works with compatible versions of Apple AirPods Pro.

• It is for people 18 and over with perceived mild to moderate hearing loss (FDA).
• Users can adjust it without help from a professional (FDA).
• Setup is done from an iOS device (FDA).
• It was authorized through the De Novo pathway for new low- to moderate-risk devices (FDA).

This is a decision of the US regulator. On its own it says nothing about the situation in Israel.

European Union and United Kingdom

European Union. Regulation (EU) 2017/745 sets the rules for placing medical devices on the market. Under it, CE marking is the mark by which the manufacturer indicates that the device meets the requirements. This page does not go into device classes or procedures.

United Kingdom. According to the UK government, a medical device sold in Great Britain needs UKCA or CE marking, and acceptance of CE marking has end dates. Devices must be registered with the MHRA before they are sold, and the MHRA monitors the market. Northern Ireland follows different rules. According to the NHS, you can start with a GP and be referred to an NHS provider, or go directly to a private provider.

Israel: registration in the AMAR register

In Israel, the Medical Devices Division (AMAR) of the Ministry of Health is responsible for registration. According to the ministry, medical equipment is manufactured and marketed only if it is registered, and under the conditions of that registration; the aim is safety and effectiveness. Bringing medical equipment in through customs also requires the ministry's approval.

In plain terms: approval in the US, the EU or the UK is not the same as registration in Israel. Ask the seller whether the device is registered with AMAR. For questions about funding, the right source is your health fund (kupat holim) and the Ministry of Health website; this page does not list entitlements or amounts.

At a glance

• United States: FDA; two categories, over-the-counter (18+, no professional needed) and prescription.
• European Union: Regulation (EU) 2017/745; CE marking.
• United Kingdom: MHRA; UKCA or CE, plus MHRA registration.
• Israel: Ministry of Health; registration in the AMAR register.

Before buying abroad or online: questions to check

These are questions to ask, not a recommendation to buy.

• Is the device registered with the Ministry of Health's AMAR register?
• Is there a warranty valid in Israel, and who provides it?
• Are service and repairs available in Israel?
• Is support and the app available in your language?
• Does the device work with phones sold here?
• What is the return policy, and how long is the trial period?

Key takeaways

• Each country has its own rules for medical devices.
• Over-the-counter (OTC) is a US category, for adults only.
• CE marking or FDA authorization is not registration in Israel.
• Before buying abroad, check AMAR registration, warranty and service in Israel.