Hearing Space digital audiometer versus AC40 for tone and speech hearing thresholds
Digital Audiometer vs. Conventional Audiometer (Gold Standard): Study of Tonal and Vocal Recognition Thresholds
This test will see if the Hearing Space digital audiometer (with guided self-calibration) gives the same tonal and speech recognition thresholds as the standard AC40 in adult French-speaking patients attending ENT.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier le Mans Academic / other |
| Locations | 1 site (Le Mans) |
| Trial ID | NCT07458477 on ClinicalTrials.gov |
What this trial studies
Adult French-speaking patients referred to the ENT department are enrolled and must provide written informed consent; key exclusions include unilateral cochlear deafness, pregnancy, single-ear patients, or legal guardianship. Each participant undergoes audiometry with both the Hearing Space device and the conventional AC40 in randomized order (Hearing Space first then AC40, or AC40 first then Hearing Space). Testing captures tonal thresholds and speech recognition thresholds, and the study compares agreement and clinical concordance between devices. The Hearing Space system's guided, automated transducer calibration that conforms to standards is a central feature under comparison.
Who should consider this trial
Good fit: Adults (18+) who speak French, can follow instructions, attend the ENT department for audiometric testing, have both ears without unilateral cochlear deafness, and can give written informed consent.
Not a fit: Patients with confirmed unilateral cochlear deafness, only one ear, non-French speakers, children, those unable to consent or follow instructions, pregnant women, or adults under guardianship are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the Hearing Space device could offer accurate, easier-to-use audiometry with self-calibration and help broaden access to reliable hearing tests.
How similar studies have performed: Previous studies comparing digital or tablet audiometers to conventional clinical audiometers have shown promising agreement, although devices with automated self-calibration like Hearing Space are newer and less extensively validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who have come to the ENT department for an audiometric examination * Adult patients (aged 18 or over), regardless of weight, gender, ethnicity, etc. * Patients whose native language is French. * Able to understand instructions. Person affiliated with or beneficiary of a social security system. * Free, informed, and written consent signed by the participant and the investigator (no later than the day of inclusion and before any examination required by the research). Exclusion Criteria: * Patients with known/confirmed unilateral cochlear deafness * Adults deprived of liberty or under guardianship * Pregnant women * Patients with only one ear
Where this trial is running
Le Mans
- Centre hospitalier du Mans — Le Mans, France (Recruiting)
Study contacts
- Study coordinator: Christelle JADEAU
- Email: cjadeau@ch-lemans.fr
- Phone: +33244710781
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.