SoundHealth has secured approval from the US Food and Drug Administration (FDA) for the paediatric use of its SONU Band, designed to alleviate moderate to severe nasal congestion in children aged 12 and above.
The wearable medical device device, which employs artificial intelligence (AI), is the first of its kind to receive FDA De Novo authorisation as a non-pharmaceutical treatment for both allergic and non-allergic rhinitis.
The SONU Band is reported to be effective, with over 80% of users experiencing improvement in nasal symptoms.
According to SoundHealth, the device offers a new category of rapid relief therapies that mitigate the side effects often linked with traditional pharmaceutical treatments.
The company said that the device operates through an innovative approach where it uses acoustic vibrational energy to relieve congestion.
By producing resonant sound waves, it gently vibrates the nasal cavity, reducing swelling and opening nasal passages.
SoundHealth’s proprietary AI technology scans the patient’s face using a smartphone app to create a digital map of their sinuses. This process calculates optimal resonant frequencies tailored for each user.
Once scanned, patients place the SONU Band around their head, activating it to deliver these personalised frequencies.
Research suggests that acoustic vibration, akin to humming, can decrease nasal congestion symptoms. This effect may be due to modulation of autonomic inputs or nitric oxide activity, which could provide decongestant and anti-inflammatory benefits.
The band aims to provide relief within 15 minutes, offering a fast-acting alternative for managing nasal symptoms without medication.
SoundHealth founder and CEO Paramesh Gopi said: “Nasal congestion and allergies don’t have to be life-altering.
“Our team of scientists, engineers and medical professionals has truly revolutionised respiratory health with AI-powered sound therapy. We are thrilled to now be able to offer relief from congestion to children and will continue to work toward helping people breathe better.”
