You’re sitting in the hearing care professional’s office, and he says, “This model is listed in the Medical Devices Directory.” It sounds official, but what does that mean for you? There’s more to this statement than meets the eye. The Medical Devices Directory specifies which hearing aids your health insurance provider can reimburse and what level of performance these devices must meet. In this way, the Medical Devices Directory ensures consistently high quality in hearing care.
What is a list of assistive devices, and why does it exist?
The GKV Medical Aid Catalog is an official catalog published by the GKV-Spitzenverband. The GKV-Spitzenverband—the umbrella organization for statutory health insurance funds—lists all products that are generally eligible for coverage by statutory health insurance funds.
This includes many everyday assistive devices, such as wheelchairs, prosthetics, vision aids, and hearing aids. A product is only included if the manufacturer provides specific documentation, for example, regarding its function, safety, and quality.
Important: Whether and to what extent your health insurance provider covers the costs always depends on medical necessity, the prescription, and the applicable contracts.
Good to know: Hearing aids are medical devices
As medical devices, hearing aids are subject to strict legal requirements regarding their technical specifications, safety, and effectiveness. Only certified products are included in the medical device directory. The legal basis for this is Section 139 of Book V of the Social Code (SGB V) (Medical Device Directory) and Section 33 of Book V of the Social Code (SGB V) (Entitlement to Medical Devices).
More information: https://www.youtube.com/watch?v=Cx7bMJsp2Ho
Hearing Aids in the Directory: Product Group 13
Hearing aids are listed in what is known as Product Group 13—hearing aids. This group includes a wide variety of device types and designs:
- Traditional hearing aids (e.g., behind-the-ear or in-the-ear devices)
- Bone-conduction hearing aids
- Signal systems—devices that alert the user to a doorbell, telephone, or smoke detector via visual cues or vibration
Many people with hearing loss are not even aware that signal systems exist. Yet they can make a big difference in everyday life, for example, if you can no longer hear the doorbell.
For a hearing aid to be included in the GKV Medical Devices Directory, the manufacturer must demonstrate that the product is safe, functions properly, and meets the specified quality requirements. If necessary, the medical benefit must also be substantiated.
For hearing aids, this includes, among other things, technical documentation and testing. Tests conducted by the German Hearing Aid Institute (Deutsches Hörgeräte Institut) or equivalent evidence from other independent testing institutes are frequently used for this purpose.
In addition, the manufacturer must ensure that technical operability and the availability of replacement parts are guaranteed for at least six years after the product is discontinued.
What does the information in the assistive devices directory mean for me specifically as a hearing aid user?
The Medical Device Directory protects you. It ensures that the hearing aids covered by your health insurance plan are of high quality. And it provides clarity on what insured individuals are entitled to.
What does health insurance cover—and what doesn't?
Your health insurance plan covers the costs of high-quality hearing aid fitting. This includes hearing aids that fully meet the requirements of the GKV Medical Aids Directory and compensate for your hearing loss without any out-of-pocket costs.
Would you like more features, such as:
- Bluetooth connectivity to your smartphone
- particularly extensive comfort or automatic features
- particularly small or discreet designs
then you can pay an additional copayment yourself for these extras. This allows you to make your daily life with hearing aids even more fulfilling.
Tip: Convenience features such as Bluetooth or automatic noise cancellation are very practical. For many hearing aid users, they make a noticeable difference in everyday life—for example, when talking on the phone, watching TV, or dining in busy restaurants. Talk openly with your hearing care professional about what’s important to you in terms of optimizing the sound quality of your life.
You can learn more about this in our article “Hearing Aid Reimbursement—Who Pays for My Hearing Aids?”
Comparing Made Easy
Because the directory sets uniform minimum standards, you can better evaluate offers. You know that every listed product has proven its quality. Anything beyond that is a convenience—one that you can tailor to your specific needs.
The directory remains up to date
The list of medical devices is as dynamic as technological progress and is therefore updated regularly. New hearing aids can be added through an expedited process. This allows insured individuals to benefit more quickly from new technological developments.
Your hearing care professional is familiar with the assistive devices directory
The list of assistive devices is extensive, but you don't have to work through it on your own. That's exactly what your hearing care professional is there for. They are familiar with:
- the latest hearing aids and their features
- the requirements of the medical devices directory
- the contracts with your health insurance provider
Your hearing care professional will explain clearly what your insurance covers, what you’ll need to pay out of pocket, and why certain comfort features might be beneficial for your lifestyle.
You can also learn more about this in our article “Tips for Choosing: How Do I Find the Right Hearing Aids for Me?”
Find a hearing care professional near you using our hearing care professional search tool.
Good to know: Listed hearing aids meet specific requirements
If a hearing aid is listed in the GKV Medical Devices Directory, the manufacturer has provided the necessary documentation—for example, regarding safety, functionality, and quality. For you, this means that the hearing aid meets the requirements for statutory coverage and may be covered by your health insurance provider.
The directory also helps you better evaluate different offers. You can see: Which devices are medically necessary? What is covered by insurance? And which additional features are simply a matter of personal preference?
At your next appointment, talk openly with your hearing care professional about which solution fits your everyday hearing needs—and which costs your health insurance will cover or what co-payment options are available.