Sono is the result of an international startup collaboration involving inventors, academics, clinicians, and hearing industry experts. Our goal has been to develop evidence-based tinnitus technology into an affordable medical device that patients can use at home.
Bringing Sono to market has been an exciting startup journey, despite the global challenges of the last few years. Here are some of our milestones to date:
Founding: Cleanhearing company was formed after a meeting between Hidero, a Japanese tech entrepreneur and Gerald, an engineer from Austria, who had adapted pulsed electromagnetic stimulation technology to successfully treat his own chronic tinnitus. Their goal was to create an affordable medical device for tinnitus relief that patients can use at home.
Anchor investment: Kyoto University in Japan made an anchor investment in the pre-seed round, so work on the prototype could begin. We established our scientific advisory board and expanded the team to begin development.
Prototype: We finalized the prototype for the Sono medical device, consisting of a handheld controller and headphones for delivery of the pulsed electromagnetic fields. Bluetooth and WiFi functionality were added to enable a number of additional add-on functions.
Innovation awards: The Cleanhearing team were invited to enter the Japan round of the prestigious Falling Walls Venture competition for health technology startups. We achieved first place and were chosen to represent Japan in the global finals in Berlin, where we were placed in the top 3 globally for our category.
Pre-seed round: We closed our pre-seed funding round of US$ 1.3M and confirmed our manufacturing partners, including a well-known Japanese headphone maker, and specialist Taiwanese medical device manufacturer.
Regulatory approvals: After successfully completing the necessary audits and other preparation, we achieved our EN ISO 13485 certification, and our CE certification as a Class IIa medical device for tinnitus (EU Medical Device Directive 93/42/EEC).
Manufacturing: By early 2021, our manufacturing partners had completed the tooling and started on the first round of manufacturing and testing. Our first batch of Sono devices was completed in March 2021.
App release: We released the Cleanhearing tinnitus app on the App Store and Google Play offering a second, complimentary notched music therapy and masking files for users to further tailor Sono treatment to their own unique tinnitus condition.
May- Dec. 2021
Website and launch: We completed work on the website and Cleanhearing went on sale in the UK and Europe. Later in 2021, we introduced 2-month, 4-month and 6-month rental options, and started preparations for clinical trials to run in the US and Japan.