Congenital middle and external ear malformation with hearing loss
Conditions
Interventions
BAHA5 Wearing Group:Assist subjects who meet the inclusion criteria in wearing and using BAHA5 hearing aids. With the hearing aids on, evaluate the subject's hearing threshold, speech recognition rate
Sponsors
Department of Otolaryngology, Head and Neck Surgery, Sun Yat sen Memorial Hospital, Sun Yat sen University
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1) Chinese population aged over 5 and under 18 (including 5 and 18 years old); 2) According to the judgment of the main researchers, they can understand and retell Mandarin; 3) The subjects signed informed consent forms and had good compliance; 4) Unilateral microtia type 3 patients.
Exclusion criteria
Exclusion criteria: 1: Currently using other bone guided hearing aids, such as BAHA Attract, bone bridge, etc 2: Known to have life-threatening diseases 3: Known to have diseases that may interfere with medical outcomes, such as local skin infections, ulceration, necrosis, proliferation, etc. near deformed ears 4: Known psychological or mental issues that may interfere with compliance, understanding, knowledge, and cooperation abilities 5: Individuals with speech comprehension disorders 6: Researchers believe that situations that may hinder the evaluation of results or pose health risks to subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pure tone audiometry;Speech recognition rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sound source localization capability;Event related potential P300;Percentage of subjects with significantly improved hearing aid effectiveness;The change in signal-to-noise ratio recognition threshold measured by hearing tests in noise before and after wearing the test device by the subject;Satisfaction with evaluating the appearance, physical and mechanical properties, ease of use, and frequency of malfunctions of the device;APHAB score for evaluating the effect of hearing aids on subjects before and after wearing the test equipment; | — |
Countries
China
Contacts
Public ContactSuijun Chen
Sun Yat sen University Sun Yat sen Memorial Hospital, No. 107 Yanjiang West Road, Yuexiu District, Guangzhou City, Guangdong Province
Outcome results
None listed