Innovative hearing technology startup Cleanhearing has launched Sono, a CE approved medical device and new treatment option for tinnitus patients in the UK.
Tinnitus is a debilitating condition impacting around six million people in the UK alone leading to a reduction in life quality and a burden on the social and health system. While often linked to age-related hearing loss or to occupational noise exposure, tinnitus can also be caused by certain medications or illnesses and has recently been linked to Covid-19 infection.
Despite its prevalence, individuals suffering from tinnitus face a limited choice of treatments with the focus often on masking, coping, or treating related conditions such as anxiety or hearing loss rather than tackling the tinnitus itself. In some cases, patients are told there is nothing that can be done for them and are left without any hope of relief.
To solve this problem Cleanhearing, a small international startup whose team spans the UK, Austria, and Japan, has put four years of research and development into creating Sono, a portable medical device that applies gentle electromagnetic stimulation to relieve tinnitus at home.
Electromagnetic stimulation is an evidence-based treatment that targets underlying contributors to tinnitus, and has been shown to modulate tinnitus-related brain activity and relieve tinnitus symptoms. The Cleanhearing team has developed this technology into a convenient multimodal system for home use with the assistance of a world-class scientific advisory board, which includes Professor David Friedland and Professor Christina Runge, specialists in hearing disorders at the Medical College of Wisconsin, and Dr. Herbert Bächler, previously CTO of hearing technology market leader Phonak Sonova.
“Sono is the only medical device approved to deliver electromagnetic stimulation specifically for tinnitus outside a clinical setting,” explains Gerald Neuwith, Cleanhearing CTO and chief engineer, who developed the first prototype to successfully treat his own severe tinnitus of eleven years. “Its patented delivery method optimizes very low-strength, low-frequency electromagnetic energy, providing a safe, gentle treatment that is suitable for home application.”
The specialized coils that deliver Sono’s electromagnetic therapy are housed inside comfortable headphones and operated by a handheld touchscreen controller. Patients are advised to use Sono twice a day for twenty minutes while seated and relaxing with results expected within two to four months of regular use.
Gerald highlights benefits of the home treatment approach. “Patients can use Sono at home either independently or under their doctor’s supervision. This helps to reduce possible stress triggers associated with waiting lists, travel, and appointments. It also minimizes interruptions to treatment caused, for example, by recent pressures on healthcare services. Patients are also more likely to continue with a treatment if it is comfortable and convenient.”
Gerald Neuwirth, Cleanhearing CTO, presents a Sono device from the first production batch
As part of Sono’s development, Cleanhearing has also launched a free tinnitus app that delivers notched music simultaneously with the electromagnetic therapy. Notched music is shown to be beneficial for a subset of tinnitus patients who experience tinnitus as a single pure tone. “Patients can download the app and input their tinnitus frequency, which is then notched out of their music tracks to create a tailored therapy,” explains CEO, Dr. Hidero Niioka, who co-founded the company. “Notched music has been shown to lower the perceived intensity of tinnitus and can offer long term results. This multimodality is one of the features that makes Sono such a unique and individualized treatment option.”
Both Sono and the notched music app can be used without a prescription, but the company states that anyone suffering from tinnitus should get their condition checked by a qualified professional before undertaking any form of treatment. If used under medical supervision, Sono offers an optional diary with cloud connection that allows patients to track and share their progress data with their doctor.
Cleanhearing received CE approval for Sono as a medical device for tinnitus earlier this year and has completed manufacture of the first batch of devices, which are now available to order from the company’s website. Launching it has not been without its challenges however. “It has taken a huge effort to develop our prototype into a mass-produced, CE-certified device within just four years given the fallout of the US-Chinese trade war and the impact of COVID-19,” says Hidero. “Increases in materials pricing and shipping costs as well as travel restrictions were unexpected, but we were able to navigate these to launch this year thanks in large part to the strong support of our manufacturing and other partners.”
A priority for Cleanhearing now is scaling up and raising further funds. “We are talking to international investors and hope to close a financing round within the next few months.” Cleanhearing previously raised $1.4 million in its pre-seed round with investors including Kyoto Innovation Capital, the fund of the prestigious University of Kyoto, Sosekai, one of the largest clinic and hospital chains in Japan, and Paris Miki, a global optometrist chain with over 1000 stores worldwide. The startup is also looking for sales partners who specialize in hearing aids and other medical supplies.
While currently focused on the UK and Europe, Cleanhearing has global ambitions with country-by-country expansion planned. It’s a big challenge, but that doesn’t faze the team. “We want to make Sono available worldwide. Tinnitus is a massive global problem and we want to be a large part of the solution. We know this is just the start of a long journey, but we are excited about what is ahead.”