720186BAHA Cleaning Accessory DeviceClosedGRD Development of PrototypeInnovate UKSapere Systems aims to develop a product to remove bacterial biofilm formed on an implanted medical device, a bone anchored hearing aid (BAHA) to reduce infection at the interface between the BAHA and the skin. Hearing loss is a major problem worldwide, in the UK more than 10 million people are affected with some form of hearing loss. This is not just the elderly: from the UK total, 3.7 million are of working age (16 – 64). A BAHA is a medical device using bone conduction where hearing loss is due to a fault in the sound conducting mechanism, for people who cannot otherwise wear an 'in the ear' or 'behind the ear' hearing aid and for single-sided deafness. BAHAs use a titanium prosthesis surgically embedded into the skull with a small abutment exposed outside the skin. A sound processor sits on this abutment and transmits sound to the titanium implant. This sound energy then bypasses the conducting mechanism of the normal ear through the skull thereby stimulating the cochlea or organ of hearing. The BAHA is a well established, successful and growing treatment for hearing loss, with more than 110,000 implantees worldwide. However the commonest complication is infection at the site of skin penetration and up to 30% of all implanted patients have skin reactions requiring treatment. In severe cases this can lead to failure of the device or the need for repeated surgery. A study by a UK group including one of Sapere’s founders, of retrieved, failed BAHAs showed biofilm formation on the BAHA components implicating biofilm in the failure. This complication could be reduced with adequate cleaning of the BAHA abutments, which is currently achieved by using a toothbrush, which Sapere’s studies have shown to be ineffective. Sapere has designed a biodegradable cleaning accessory that is simple to use; early tests show that this single use accessory removes the biofilm from the abutment surface and all BAHA wearers and future implantees will benefit from the device accessory.