GuidelinesBy device type2026.10.14
Hearing Aid Imports into Korea: Review the Receiver, Earpiece and Fitting Software Together
Brand and appearance do not define a hearing aid family. Connect hearing-assistance purpose, receiver and earpiece combinations, acoustic evidence, fitting software and Korean instructions before import.
Assess the actual configuration formed by the aid, receiver, earpiece and fitting software. A main model name alone does not connect evidence to the product shipped.
1. Document the hearing-assistance purpose
MFDS safe-use information describes the medical purpose of hearing aids that amplify sound to assist people with hearing loss. This guide concerns documentation for conventional non-implantable products. Do not automatically apply its checklist or route to implantable, bone-conduction or other designs.
Read instructions and advertising rather than relying on overseas sound-amplifier or listening-assistance labels. Record the intended hearing condition, whether professional fitting is assumed, and the user's adjustment range. Overseas retail arrangements alone cannot establish Korean consumer-product status or a particular class.
2. Split the sales family into acoustic configurations
The same main unit may use different receivers, tubes, earpieces or earmoulds. Distinguish colour-related sales codes from differences affecting performance and identify each tested combination. This is an evidence-request table, not an official application form.
| Component | Information | Supporting evidence |
|---|---|---|
| Main aid | Model, microphone and processing, power | Design and acoustic reports |
| Receiver and tube | Code, output characteristics, connections | Tested configuration list |
| Earpiece and mould | Size, material, contact | Suitability and biological evaluation |
| Fitting software | Version, adjustment range, permissions | Verification and change history |
| Charger and wireless | Model, connections, functions | Safety and communication evidence |
Where the report matches only the main aid, explain the difference in receivers. Commercial family grouping does not itself establish representative test coverage.
3. Match output and gain to test conditions
Before transferring catalogue values into technical documentation, check the configuration, settings, standard and test method. For adjustable products, identify the settings used to obtain the values. Ensure that claims stay within the report's supported scope.
Review report content as well as the cover, including accessory and software identities. Korean submission suitability requires a separate assessment. The foreign report guide helps separate reusable evidence from conditions needing clarification, making quotation assumptions clearer.
4. Define the boundary between fitting and user operation
A professionally fitted aid with user volume control has a different workflow from an app with extensive self-adjustment. Record who can change each setting, how limits operate and what values a reset restores. Software that is not sold separately can still affect device safety and performance.
An app providing connectivity alone differs from one changing acoustic output or programmes. Assess applicable radio requirements for wireless functions without treating radio conformity as a substitute for medical performance evidence. See the KC and radio certification guide.
5. Align wear and maintenance instructions with supplied components
MFDS safe-use advice includes avoiding sharing and obtaining professional adjustment. Product instructions should connect fitting, removal, cleaning, storage and problem handling to the actual configuration. Compare general advice with the manufacturer's validated conditions and registered use instead of simply copying it.
Small replaceable parts, batteries and chargers need clear identification. Match codes to illustrations and distinguish single-use parts, reusable parts and user-replaceable components. Do not copy professional fitting instructions directly into general-user material or mix cleaning diagrams from different models.
6. Connect the first order to change notification and support
Agree on notification and evidence responsibilities for receiver-code or fitting-software changes even when the main model remains unchanged. Complaint enquiries should be able to identify accessory combinations and software versions as well as serial numbers. This traceability practice is a practical recommendation, not a claim that an additional universal statutory form exists.
Bring the Korean model list, receivers and earpieces, software information and reports to request a hearing aid import review. Clare Partners can first compare registration scope with the tested and documented configuration.
Official references: MFDS hearing aid safe-use information · Korean medical device review regulation. Checked 2026-09-28. Classification and evidence scope depend on intended use and design. Tables and review order are practical recommendations.
Frequently asked questions
- Q. Does an overseas listening-assistance label make it a general consumer product?
- The label alone does not determine status. Assess intended hearing assistance, functions and actual labelling and advertising against Korean requirements.
- Q. Can we reuse evidence when only the receiver changes?
- Receivers and earpieces can affect acoustic performance and use conditions. Compare tested and marketed configurations and establish what the evidence represents.
- Q. Should fitting software be reviewed if it is not sold separately?
- Where it influences settings or output, include its version, adjustment range, connection conditions and verification in the product assessment. Separate regulatory treatment depends on function.