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Development and clinical validation of a new hearing aid with intelligent electrical valve

Development and clinical validation of a new hearing aid with intelligent electrical valve

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081766
Enrollment
Unknown
Registered
2024-03-11
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hearing disorders

Interventions

control group(own hearing aids):No interventions, it's observational study.Only conduct relevant inspections (three times)
experimental group(hearing aid with intelligent electrical valve ):Install a new intelligent electrical valve hearing aid for the participants in this group and conduct relevant inspections (three tim

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? Chinese population aged 18 to 80; ? Diagnosed as patients with moderate or severe conductive hearing loss, typed as sensorineural hearing loss or mixed hearing loss; ? No stenosis of the external auditory canal, foreign bodies in the ear, and middle ear tumors, not in the progression stage of otological diseases; ? Can understand and retell Mandarin.

Exclusion criteria

Exclusion criteria: ? Currently using other hearing aids (for the experimental group); ? Individuals who are allergic to components of products such as epoxy resin polymers; ? Known psychological or mental issues that may interfere with compliance, understanding, informed and cooperative abilities, or individuals with speech comprehension disorders

Design outcomes

Primary

MeasureTime frame
pure tone threshold;Speech recognition rate;

Secondary

MeasureTime frame
questionnaire investigation;

Countries

CHINA

Contacts

Public ContactFeng Yanmei

Shanghai Sixth People's Hospital

ymfeng@sjtu.edu.cn+86 189 3017 3985

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026