ICF: From Early Music Audiometry to Tone Audiograms (FERMATA)

Testing the hearing of children with social and communication delays (SCD) is hard, often leading to misdiagnosis and delays to care. Half of these children cannot be diagnosed via the gold-standard of headphone audiometry according to a recent study [1]. They have difficulty staying still, wearing headphones, and responding to 'uninteresting' sounds. In fact, some children will only respond to their favourite songs. Nevertheless, a skilled audiologist can get reliable behavioural hearing ‘indicators’ using music with the correct equipment/techniques. Today using music only gives ‘indicative’ hearing thresholds because the music signal is constantly changing, making it hard to determine the frequencies and levels to which the child responded. So, until now this technique has been limited to advanced audiologists—who often create and filter their own music signals. Furthermore, although current audiological equipment is calibrated to produce the required stimulus level at the ear, none has yet used available technology to quantify the levels/frequencies at the ear at the time a response was observed. In October 2022, a consortium of 5 partners was awarded a 3-year 431k GBP Biomedical Catalyst Grant #10037793 titled “Paediatric Music-based Audiometry” from Innovate UK. In this grant Audio3 Ltd. (lead SME organization) manages and works closely with 4 partners, including the 3 partners here: Guy’s and St Thomas’s NHS Foundation Trust (the largest paediatric audiology clinic in the UK), London Southbank University (acoustics), and Chear Ltd. (leading private audiology clinic). Now completing Year 2, the project is on track to produce a music-based Paediatric Audiometer (Class-IIa Medical Device) to help diagnose children---especially those with social and communication delays (SCD)---with higher accuracy/simplicity than previously possible. We intend our device to become the preferred standard in this emerging area. That grant is proceeding well. We have a working prototype in situ in the clinics and are testing. However, there is a gap in our knowledge which needs to be addressed. We do not know how the intensity levels needed to recognize a familiar tune relate to absolute detection levels used in traditional audiometry assessment. This is a crucial piece of information because it is the pure-tone audiogram that drives downstream treatments. Without the audiogram, the diagnosis cannot link to treatment. In this study we will use the Music Audiometer prototype in an investigational device study (e.g. MDR Article 82) using both NHS and private adult and teenage patients for whom we can get pure tone audiograms in order to correlate and quantify the difference between these methods. This gap needs to be understood before seeking a full clinical study on young children. [1] New methods of behavioural hearing testing in young children with social and communcation disorders J. Marriage, K. Joseph and B. Backus Manchester Centre for Audiology and Deafness Conference (ManCAD) Manchester, UK Sept 16-17, 2024 2024.