From Early Music Audiometry to Tone Audiograms (FERMATA)

Understanding the Role of Band-pass Filtered Familiar Music Stimuli for Use in the Assessment of Hearing

Hearing tests are crucial for a child's development, but the standard test, Visual Reinforcement Audiometry (VRA), often doesn't work for those with social communication disorders (SCD) and autism spectrum disorder (ASD). A standardised filtering tool has been developed. Understanding how the results from this new music test compare to standard test results, particularly in people with hearing loss, is critical to establishing the fundamental psychoacoustic threshold relationship. This basic science research validates the acoustic methodology before any future clinical diagnostic application can be considered

Study Overview

• Status: Not yet recruiting
• Conditions: Hearing Loss; Audiometric Tests
• Intervention / Treatment: Other: Soundfield Behavioral Audiometry

Detailed Description

BACKGROUND AND SCIENTIFIC RATIONALE:

Visual Reinforcement Audiometry (VRA) is the standard behavioral hearing assessment for children with a developmental age of 6 months to 2.5 years, achieving successful threshold determination in up to 92% of neurotypical children. However, testing success drops to approximately 50% in children with Social Communication Disorders (SCD) and Autism Spectrum Disorder (ASD). Incomplete assessments delay the identification and management of permanent hearing loss, impairing speech and language development. To improve test compliance, clinicians frequently present familiar music stimuli (FMS) in the sound-field. Some services apply manual band-pass filtering (BPF) to these music files to isolate discrete octave bands. However, current practice relies on time-consuming, non-standardized off-the-shelf audio editing tools, leading to high acoustic variability across centers. Crucially, the relationship between BPF-FMS behavioral response thresholds and gold-standard puretone/ warble-tone audiometric thresholds remains unknown in listeners with hearing loss, preventing clinicians from accurately plotting music responses onto standard diagnostic audiograms. This non-interventional basic science study utilizes a novel prototype software interface developed by Audio3 Ltd to deliver standardized, octave-band filtering of familiar music stimuli. The project evaluates the fundamental psychoacoustic threshold relationship between BPF-FMS, narrow-band noise (NBN), and goldstandard warble tones in listeners with confirmed permanent hearing loss.

STUDY STRUCTURE AND EXPERIMENTAL DESIGN:

The project operates across seven work-packages (WPs):

1. WP1 (Management): Governance and steering committee oversight across the 17-month study lifecycle.
2. WP2 (Filtering Strategy & Acoustic Verification): In situ free-field calibration and acoustic verification (complying with BS EN ISO 8253-1 across soundproof booths at Guy's and St Thomas' NHS Foundation Trust (GSTT) and CHEAR Ltd.
3. WP3 (Clinical Setup): Finalization of research protocols, ethical approvals, and data management architecture.
4. WP4 (Initial Data Collection - Phase 1): Comparative behavioral soundfield testing in 50 participants with confirmed permanent bilateral hearing loss (35 children/teenagers at GSTT; 15 participants at CHEAR Ltd).
5. WP5 (Analysis & Optimization): Statistical modeling (Bland-Altman analysis and Linear Mixed-Effects Models) to evaluate threshold agreement between BPF-FMS and warble tones. The filtering parameters (bandwidth, slope, time-windows) are refined based on Phase 1 data.
6. WP6 (Review Data Collection - Phase 2): Repeat testing protocol using the optimized BPF-FMS filtering strategy in an independent cohort of 50 participants (35 at GSTT; 15 at CHEAR Ltd).
7. WP7 (Final Analysis & Dissemination): Final synthesis, reporting, and deposition of anonymized datasets to open science repositories.

TESTING PROCEDURE (PARTICIPANT EXPERIENCE):

All testing takes place in a single 15-minute session immediately following a routine, standard-of-care diagnostic hearing appointment:

• Setup: Testing is conducted in a soundproof booth meeting BS EN ISO 8253-1 standards using calibrated diagnostic audiometers (Otometrics Astera2 at GSTT; Interacoustics AC40 at CHEAR Ltd).
• Stimuli Profile: Participants are evaluated in the binaural sound-field at four standard frequencies (500, 1000, 2000, and 4000 Hz) under four distinct acoustic conditions: (1) Warble Tones, (2) Narrow-Band Noise, (3) BPFFMS Soundfile 1, and (4) BPF-FMS Soundfile 2. Unfiltered broadband music is also presented.
• Counterbalancing: Test condition order (1-4) is fully counterbalanced using 24 cyclic permutations to eliminate order, fatigue, and practice effects.
• Response Mechanics: Participants indicate sound detection via standard button-press mechanics in accordance with British Society of Audiology (BSA) recommended procedures.
• Recognition Assessment: Following testing, participants report whether the musical stimuli were familiar, unfamiliar, or unsure.

SAFETY AND DEVICE POSITIONING:

The prototype filtering software acts strictly as a signal-processing tool to standardize stimulus parameters and does not perform active medical diagnosis or treatment. Maximum volume outputs are hardcoded within the software interface to guarantee testing remains within safe acoustic limits. All hardware output devices remain unmodified, CE-marked medical audiometers calibrated to BS EN ISO 389 standards.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Keiran D Joseph, MSc; Phone Number: 07929615170; Email: keiran.joseph@nhs.net

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • Guy's and St Thomas NHS Foundation Trust
    • Contact: Keiran D Joseph, MSc; Phone Number: 07929615170; Email: keiran.joseph@nhs.net
  • Royston, United Kingdom, SG8 6QS
    • CHEARLtd
    • Contact: Josephine Marriage, PhD; Phone Number: 01763 263333; Email: info@chears.co.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children, teenagers, and adults aged 7 to 45 years with confirmed, stable, permanent bilateral hearing loss (4-frequency pure-tone average ≥25 dB HL in the better hearing ear) who are able to reliably perform pure-tone audiometry. Participants are sampled from the active clinical caseloads at Guy's and St Thomas' NHS Foundation Trust (GSTT) Paediatric Audiology service and CHEAR Ltd.

Description

Inclusion Criteria:

• Aged 7 to 45 years old
• Able to reliably perform conventional Pure Tone Audiometry
• Confirmed stable bilateral hearing loss with a 4-frequency (500, 1000, 2000, 4000 Hz) pure-tone average ≥25 dB HL in the better hearing ear

Exclusion Criteria:

• Aged under 7 or over 45 years old
• Unable to complete reliable conventional audiometry task mechanics
• Satisfactory hearing or purely unilateral hearing loss (4-frequency pure-tone average in better ear <25 dB HL)
• Fluctuating or unconfirmed hearing threshold variations
• History of Auditory Processing Disorder (APD)
• History of Auditory Neuropathy Spectrum Disorder (ANSD)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Phase 1 Cohort (Initial Filtering Strategy); 50 participants (35 recruited at GSTT and 15 at CHEAR Ltd) with confirmed stable permanent bilateral hearing loss, evaluated using the initial baseline band-pass filtered familiar music stimuli (BPF-FMS) strategy (Work-Package 4)	Other: Soundfield Behavioral Audiometry; Single 15-minute behavioral soundfield hearing detection task comparing conventional warble tones, narrow-band noise, and band-pass filtered familiar music stimuli (BPF-FMS). Group 1 receives BPF-FMS generated via the baseline filtering algorithm; Group 2 receives BPF-FMS generated via the optimized filtering algorithm
Phase 2 Cohort (Optimized Filtering Strategy); 50 independent participants (35 recruited at GSTT and 15 at CHEAR Ltd) with confirmed stable permanent bilateral hearing loss, evaluated using the updated/optimized band-pass filtered familiar music stimuli (BPF-FMS) strategy refined following Phase 1 analysis (Work-Package 6	Other: Soundfield Behavioral Audiometry; Single 15-minute behavioral soundfield hearing detection task comparing conventional warble tones, narrow-band noise, and band-pass filtered familiar music stimuli (BPF-FMS). Group 1 receives BPF-FMS generated via the baseline filtering algorithm; Group 2 receives BPF-FMS generated via the optimized filtering algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binaural Sound-field Hearing Threshold Concordance (BPF-FMS vs. Warble Tones)	Quantified threshold agreement between band-pass filtered familiar music stimuli and gold-standard warble tones assessed via mean bias, 95% limits of agreement, and the proportion of matching observations falling within ±5 dB and ±10 dB targets	At time of testing (Single 15-minute appointment session)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Threshold Discrepancy Compared to Narrow-Band Noise	Comparative absolute error variations of BPF-FMS thresholds against Narrow-Band Noise (NBN) thresholds using linear mixed-effects modeling across identical test sound-field frequencies (500, 1000, 2000, and 4000 Hz)	At time of testing (Single 15-minute appointment session)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acoustic Signal Recognition Threshold Offset	Evaluation of absolute error threshold differences across three self-reported music profile variants (Familiar vs. Not Familiar vs. Unsure)	At time of testing (Single 15-minute appointment session)

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: London South Bank University; Audio3 Ltd; CHEAR Ltd
• Investigators: Principal Investigator: Keiran D Joseph, MSc, Guy's and St Thomas' NHS Foundation Trust

Publications and helpful links

General Publications

• Young, J., 2020. A review of the use of children's television theme tunes as soundfield stimuli in services. BAA Magazine, pp. 18-19
• Widen JE, Johnson JL, White KR, Gravel JS, Vohr BR, James M, Kennalley T, Maxon AB, Spivak L, Sullivan-Mahoney M, Weirather Y, Meyer S. A multisite study to examine the efficacy of the otoacoustic emission/automated auditory brainstem response newborn hearing screening protocol: results of visual reinforcement audiometry. Am J Audiol. 2005 Dec;14(2):S200-16. doi: 10.1044/1059-0889(2005/022).
• BSA, 2024. Recommended Procedure: Visual Reinforcement Audiometry. British Society of Audiology
• BSA, 2018. Recommended Procedure: Pure-tone air-conduction and bone-conduction threshold audiometry with and without masking. British Society of Audiology.

Helpful Links

• Professional Practice Guidelines

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 20, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 23, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Psychoacoustics; Music Audiometry; Visual Reinforcement Audiometry; Band-Pass Filtered Stimuli; Paediatric Audiology
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Ear Diseases; Hearing Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Hearing Loss
• Other Study ID Numbers: IRAS: 351560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Following project closure and publication of primary findings, fully anonymized Individual Participant Data (IPD) containing no personal or clinical identifiers will be uploaded to the Open Science Framework (OSF) public data repository to support open science and scientific reproducibility.
• IPD Sharing Time Frame: Data will become publicly available on the OSF repository within 12 months of study completion and will remain accessible indefinitely.
• IPD Sharing Access Criteria: Unrestricted open access via the Open Science Framework (OSF) public repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No