The world’s first CE-approved medical device standalone software hearing aid.

Jacoti receives CE medical device approval for its software hearing aid Jacoti ListenApp and approval for its Quality Management System. The CE certification has been granted by the highly respected Notified Body BSI. This guarantees a safe and efficient usage for the patient.

An estimated 20% of the world has some degree of hearing loss, and hearing technology company Jacoti is now giving many of those suffering a powerful new tool to help overcome the disability. Jacoti is releasing the first standalone software hearing aid to gain CE Mark approval, the Jacoti ListenApp. The user runs the app on the iPod Touch or iPhone, and uses the standard Apple EarPods with the built-in microphone to hear and amplify outside sounds. The software applies a frequency dependent gain based on certain settings and the individual’s audiogram, and softer inputs are amplified more than louder ones. It is also equipped with noise reduction technology for more comfortable plane rides.

Receiving a Quality Management ISO 13485 certification and CE Mark approval for one of the first medical software applications and the first software hearing aid in the world demonstrates the ability of our team to efficiently design, develop and gain regulatory approval for innovative products that build a bridge between medical and consumer technology, one that is safe, effective and reliable.

Jacques Kinsbergen, Jacoti CEO

The main screen allows users to control the volume and easily switch between music and microphone modes. Jacoti ListenApp has three settings when in microphone mode:

• Natural Sound
• Clear Speech
• Comfort

The Natural Sound setting does not assume any specific listening situation and naturally amplifies sound, while Clear Speech has been optimised for speech, and the Comfort mode provides lower amplification levels to help reduce fatigue. Jacoti ListenApp is free, which will be music to any user’s ears.