Reliability of a Portable Audiometric Device Based on Active Noise-Canceling Headphones for Clinical Hearing Assessment

NCT06811610 | Recruiting DMC

• 1 other identifier: KY20242145zhadingjun
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Part One: Research Background Globally, approximately 500 million people suffer from disabling hearing loss, accounting for about 6.8% of the world's population. Hearing loss has emerged as a major global health issue. The cornerstone of hearing loss prevention and protection lies in hearing level testing. Early detection and intervention are crucial components of hearing healthcare. Currently, pure tone audiometry serves as the gold standard for hearing level testing, requiring patients to visit a hospital's standard soundproof room and complete the test under the guidance of a professional audiologist. However, existing professional audiometers are bulky, consume high power, and necessitate soundproof rooms (with background noise \<30dBA), among other drawbacks. Moreover, primary hospitals or units lack professional audiologists and soundproof rooms, making it impossible to diagnose and treat hearing loss. Therefore, a portable hearing testing device that does not require a soundproof room would be a boon for the diagnosis and treatment of hearing loss patients. Currently, Wuhan Douting Technology Co., Ltd. has produced a portable hearing testing device (E200), supporting frequencies from 125Hz to 16000Hz, covering both conventional and extended high frequencies. The frequency tolerance, total harmonic distortion, and accuracy of hearing levels fully meet the technical requirements of Grade 4 audiometers according to national standards. In addition to meeting the functional and performance requirements of general audiometers, this device offers the following technical advantages and innovations: 1. Combining active and passive noise reduction, it achieves comprehensive noise reduction of over 29dBSPL, allowing for audiometry in environments with background noise \<60dBA; 2. Supporting extended high frequencies, it can detect potential hearing damage earlier; 3. Supporting audiometry for rapid use by non-professionals, with automatic calibration, allowing non-professionals to operate by following prompts. This device is not yet on the market, and we intend to verify its reliability in assessing hearing conditions. Part Two: Research Objectives To verify the reliability of a novel portable hearing testing device in assessing hearing conditions. Part Three: Research Design Paired design Part Four: Inclusion and Exclusion Criteria Inclusion Criteria: Age: ≥6 years old, no gender restriction Able to cooperate in completing pure tone audiometry Exclusion Criteria: Patients with acute otitis media or unremovable secretions blocking the external auditory canal Patients with mental or psychological disorders or unable to cooperate with the examination for other reasons Part Five: Research Process This study will recruit volunteers from the outpatient and inpatient departments of Xijing Hospital. Each volunteer will undergo two audiological tests, with at least a 10-minute interval between the two tests to prevent intolerance to the hearing tests. Each audiological test will take approximately 6-8 minutes per subject. Consultation and Physical Examination: Researchers will collect general information, including name, gender, age, hearing status, and ear disease history; Conduct a physical examination of the ears; If a volunteer meets the inclusion criteria and voluntarily sign the informed consent form, researchers will determine the testing order using a random number method based on your enrollment sequence. Conventional pure-tone audiometry:Patients undergo conventional pure tone audiometry using the interacoustics AC40 (Denmark) with TDH39 headphones (Telephonics; Farmingdale, NY, USA). We conducte audiometric testing in a sound-proof booth (background noise\<30dBA) and evaluate the frequency range of 125-8000 Hz. Before the audiometry, patients will be asked to identify which ear have better hearing, and the ear with better hearing was tested first. This study employ the Hughson-Westlake approach, known as the " up-5 down-10 technique." The pure tone sound level was initially introduced at an estimated higher threshold and reduced by 10 dB HL after a correct response from the patient. If the patient did not respond correctly or at all, the sound level was increased by 5 dB HL. When there was a difference of 40 dB HL or more in air conduction thresholds between the ears, contralateral masking was applied to correct the cross-hearing. E200 Audiometry: Noise-canceling headphones (RAN-3500) are used for all patients during the E200 audiometry. This is conducted in a regular room (ambient noise: 42.6-58.7 dBA, measured using a standard sound level meter: AWA6292 Multi-function Sound Level Meter) adjacent to a busy hallway without a sound-proof booth to simulate an ordinary environment. The Hughson-Westlake approach and contralateral masking are applied when conducting the E200 audiometry.

Conditions

Hearing Loss, Bilateral or Unilateral

Outcome Measures

Primary Outcomes (1)

• Hearing thresholds of each frequency of two hearing detection methods

  Each participant used standard soundproof room pure tone audiometry (gold standard) and a new portable audiometry. The hearing thresholds of each frequency obtained by the two methods were recorded for each volunteer and compared

  2024.03.29-2026.06.30

Interventions

Participants were tested for hearing using a new type of hearing detection device DIAGNOSTIC_TEST

Participants' hearing was tested using a portable audiometry device (E200) based on active noise-cancelling headphones, manufactured by Wuhan Doulisten Technology Co., LTD

Participants' hearing was tested using a new portable pure tone audiometry device DIAGNOSTIC_TEST

Participants' hearing was tested using a portable audiometry device (E200) based on active noise-cancelling headphones, manufactured by Wuhan Doulisten Technology Co., LTD

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Volunteers who need hearing testing (pure tone audiometry) for various reasons or diseases are recruited from the ENT outpatient clinic or ward of Xijing Hospital

You may qualify if:

• Age:≥6 years old, regardless of gender
• Must be able to cooperate in completing pure tone audiometry

You may not qualify if:

• Acute phase of otitis media or external ear canal within the secretion blockage can not be removed
• Those suffering from mental illness or other reasons unable to cooperate with the completion of the examination Remarks: Each participant was examined by a specialist using otoscope. Those with ceruminous external auditory canal embolism or secretion blockage were cleared before audiological examination

Sponsors & Collaborators

• Xijing Hospital: lead
• Wuhan Douting Technology Co., Ltd: collaborator

Study Sites (1)

The First Affiliated Hospital of the Air Force Medical University

Xi’an, Shanxi, 710000, China

RECRUITING

Related Publications (1)

• Lee SY, Seo HW, Jung SM, Lee SH, Chung JH. Assessing the accuracy and reliability of application-based audiometry for hearing evaluation. Sci Rep. 2024 Mar 28;14(1):7359. doi: 10.1038/s41598-024-57944-9.

  PMID: 38548854 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Gender, age, disease and threshold values for each frequency of both audiometry for each participant

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• dingjun zha, Doctor of Medicine

  Department of Otolaryngology, the First Affiliated Hospital of Air Force Medical University

  STUDY DIRECTOR

Central Study Contacts

qianjin gao, medical postgraduate student

CONTACT

+86-19838825659; kydgao123@qq.com

jun Chen, Doctor of Medicine

CONTACT

+86-13689295293; edongdongcccj@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 6, 2025
• Study Start: March 29, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 6, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 2026.03-2028.12
• Access Criteria: All researchers who are interested in this study can obtain the original data of this study (excluding the personal information of volunteers, such as name, gender, age, disease, etc.). The available data include the hearing test results of each volunteer with two kinds of tests, the overall gender, age, and disease distribution of all volunteers, etc. They can obtain IPD by emailing the researcher at kydgao123@qq.com

Locations

CN (1)