Jacoti receives CE medical device approval for its software hearing aid Jacoti ListenApp® and approval for its Quality Management System

(PresseBox) ( Boechout Belgium, Barcelona Spain, )
Up to 20 % of the world population suffers from hearing loss. For the hearing technology company Jacoti, this is not just a medical problem, but also a consumer challenge. Jacoti has created a solution with its medical software applications and with that the first CE marked software-only hearing aid in the world. The CE certification has been granted by the highly respected Notified Body BSI.

"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," says Jacques Kinsbergen, CEO of Jacoti bvba.

Jacoti also wants to reach out to large populations that currently have no access to advanced hearing technology and to children in their school years.

"Hearing loss and the related communication problems are a major obstruction for children in their schooling phase. In education, losing the ability to 'listen' can be a breaking point in the fragile communication chain. If not managed, it will be a burden throughout an individual's life, with major social and economic impact. Low cost and easily accessible solutions, as developed by Jacoti, will be a turning point for the availability of hearing technology in fast developing countries," said Prof. Dr. Mohan Kameswaran a leading ENT specialist in India.

Jacoti ListenApp® is the first of its kind: a standalone software-based hearing aid. It is a combined music player and hearing aid, integrated into an off-the-shelf consumer smartphone and using off-the-shelf headphones with microphone. It has a local and remote web-based fitting platform to allow the user or the hearing expert to adapt the audio settings to the individual needs. Jacoti ListenApp® represents a fundamental change: a transition from hardware medical devices to web-integrated medical devices, a new generation of Health medical technology that will play a significant role in the field of healthcare from now on. These technologies allow for a dramatic improvement in accessibility of care.

Jacoti ListenApp® makes it possible for physicians, healthcare providers and medical experts to have remote access to consumers/patients. This functionality is supported by a remote server to provide system analysis, monitoring, and system optimisation.

Therefore, Jacoti believes that hearing loss compensation and customisation of the audio to the individual needs of the users should be part of all computer platforms with an audio output. With this in mind, Jacoti has developed Inthear®, a proprietary software library that applies real-time hearing loss compensation to audio signals. It offers a cross platform Application Programming Interface (API), which is used by all Jacoti products that provide hearing loss compensation. Together with smartphone and computer manufacturers, Jacoti is exploring innovative ways to integrate the Inthear® API into computers, consumer devices and smartphones.

Jacoti bvba is a privately held hearing technology company with offices in Boechout, Belgium and in Barcelona, Spain.
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