Grouping medical devices as Hearing Aids

Hearing aids grouping requirements

You can group Class B hearing aids from the same product owner under the following categories, and register them together:

By design

• Behind the ear (BTE)

• In the ear (ITE). ITE devices have all components of the hearing aid contained in a case shell that fits in the ear or canal.

By technology for sound amplification

• Analogue

• Digital

By communication technology

• Wireless

• Non-wireless

Accessories of the same or lower risk class may be included in the registration application.

Hearing aids grouped together using a specific hearing aid grouping, but are of different proprietary or brand names, will be listed separately on the SMDR.

Note:

• Implantable hearing devices of Class C and Class D cannot be grouped together under the device specific grouping for hearing aids. Refer to our grouping table for other available grouping terms.

• You cannot change an original hearing aid device listing to a Family grouping after hearing aids are listed on the SMDR.

Example

Manufacturer HSA Zen produces a collection of Class B hearing aids which:

• Have the same design type – in the ear

• Have the same sound amplification technology – digital

• Come in two variants of communication technology – both wireless and non-wireless

These cannot be grouped together in a single application, as they differ in communication technology. Two product registration applications have to be submitted:

1. HSA Zen hearing aids (wireless)

2. HSA Zen hearing aids (non-wireless)

Addition of new hearing aid models

You can add new hearing aid models to an existing SMDR hearing aid device listing if the new models fulfil the same device specific grouping criteria and have the same device proprietary name.

Please submit a Change Notification to make such additions.

A new product registration application has to be submitted for new devices with different proprietary names from those already registered.