Audiometric TestsLHSNCT07458477
Digital Audiometer vs. Conventional Audiometer (Gold Standard): Study of Tonal and Vocal Recognition Thresholds
A study testing Hearing Space audiometer first, then AC40 audiometer and AC40 audiometer first, then Hearing Space audiometer in people with Audiometric Tests, run by Centre Hospitalier le Mans at 1 site in France.
Trial summary
According to the WHO (February 2, 2024): More than 5% of the world's population, or 430 million people (including 34 million children), need rehabilitation services due to disabling hearing loss. It is estimated that 700 million people will be affected by 2050, or one in 10 people. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Audiometric Tests
- What is being tested?
- Hearing Space audiometer first, then AC40 audiometer and AC40 audiometer first, then Hearing Space audiometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 7 Nov 2025to 12 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Patients with known/confirmed unilateral cochlear deafness
- Adults deprived of liberty or under guardianship
- Pregnant women
- Patients with only one ear
Trial locations and contacts
1 site in 1 country.
About this study
According to the WHO (February 2, 2024): More than 5% of the world's population, or 430 million people (including 34 million children), need rehabilitation services due to disabling hearing loss. It is estimated that 700 million people will be affected by 2050, or one in 10 people. It is estimated that by 2050, nearly 2.5 billion people will have some degree of hearing loss.
In most cases, audiometric testing involves determining the patient's tonal thresholds and speech recognition thresholds.
The Hearing Space device is a digital audiometer that can perform both tonal and speech audiometry. This device stands out because it allows users to calibrate its transducers themselves via a guided, automated procedure. This procedure ensures that the calibration complies with the relevant calibration standards.
- Conditions
- Audiometric Tests
- Being tested
- Hearing Space audiometer first, then AC40 audiometer, AC40 audiometer first, then Hearing Space audiometer
- Keywords
- Audiometric tests, Hearing Space Audiometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hearing Space audiometer first, then AC40 audiometerDevice
All patients will be tested by Hearing Space audiometer first, then AC40 audiometer
AC40 audiometer first, then Hearing Space audiometerDevice
All patients will be tested by AC40 audiometer first, then Hearing Space audiometer
| Study group | Role | What they receive |
|---|---|---|
| Hearing Space audiometer first | Experimental | Hearing Space audiometer first, then AC40 audiometer Receives: Device: Hearing Space audiometer first, then AC40 audiometer |
| AC40 audiometer first | Experimental | AC40 audiometer first, then Hearing Space audiometer Receives: Device: AC40 audiometer first, then Hearing Space audiometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
auditory threshold levels and speech recognition thresholds
Measurements of pure-tone audiometric thresholds and speech recognition thresholds will be taken for each of the patient's ears using the Hearing Space digital audiometer and the Interacoustic AC40 physical audiometer (in random order).
The results obtained will then be statistically compared to determine whether or not there is a significant difference between the results obtained by the two devices.
Measured: From inclusion to the end of the intervention (40 minutes on average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start7 Nov 2025
- Primary completion12 Jan 2026
- Study completion12 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Audiometric TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458477
- Sponsor's protocol ID
- CHM-2024/S33/05
- Acronym
- LHS
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Audiometer vs. Conventional Audiometer (Gold Standard): Study of Tonal and Vocal Recognition Thresholds
- ClinicalTrials.gov ID
- NCT07458477
- Acronym / sponsor ID
- LHS / CHM-2024/S33/05
- Conditions
- Audiometric Tests
- Keywords
- Audiometric tests, Hearing Space Audiometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 12 Jan 2026 (actual)
- Study completion
- 12 Jan 2026 (actual)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
According to the WHO (February 2, 2024): More than 5% of the world's population, or 430 million people (including 34 million children), need rehabilitation services due to disabling hearing loss. It is estimated that 700 million people will be affected by 2050, or one in 10 people. It is estimated that by 2050, nearly 2.5 billion people will have some degree of hearing loss.
In most cases, audiometric testing involves determining the patient's tonal thresholds and speech recognition thresholds.
The Hearing Space device is a digital audiometer that can perform both tonal and speech audiometry. This device stands out because it allows users to calibrate its transducers themselves via a guided, automated procedure. This procedure ensures that the calibration complies with the relevant calibration standards.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hearing Space audiometer first | Experimental | Device: Hearing Space audiometer first, then AC40 audiometerHearing Space audiometer first, then AC40 audiometer |
| AC40 audiometer first | Experimental | Device: AC40 audiometer first, then Hearing Space audiometerAC40 audiometer first, then Hearing Space audiometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (4 listed)
- Patients with known/confirmed unilateral cochlear deafness
- Adults deprived of liberty or under guardianship
- Pregnant women
- Patients with only one ear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hearing Space audiometer first, then AC40 audiometerAll patients will be tested by Hearing Space audiometer first, then AC40 audiometer | Device | Hearing Space audiometer first |
| AC40 audiometer first, then Hearing Space audiometerAll patients will be tested by AC40 audiometer first, then Hearing Space audiometer | Device | AC40 audiometer first |
Primary outcome
auditory threshold levels and speech recognition thresholds
Time frame: From inclusion to the end of the intervention (40 minutes on average)
Measurements of pure-tone audiometric thresholds and speech recognition thresholds will be taken for each of the patient's ears using the Hearing Space digital audiometer and the Interacoustic AC40 physical audiometer (in random order). The results obtained will then be statistically compared to determine whether or not there is a significant difference between the results obtained by the two devices.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
Related trials for Audiometric Tests
Not yet recruitingObservational study
From Early Music Audiometry to Tone Audiograms
Hearing Loss, Audiometric Tests
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hearing Space audiometer first, then AC40 audiometer and AC40 audiometer first, then Hearing Space audiometer in people with Audiometric Tests, run by Centre Hospitalier le Mans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
auditory threshold levels and speech recognition thresholds (time frame: From inclusion to the end of the intervention (40 minutes on average)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.