CUHK_CCRB00626
2018-10-08
Prospective
CREC Ref. NO.: 2017.553
Dept. of Otorhinolaryngology, Head and Neck Surgery, CUHK
Dept. of Otorhinolaryngology, Head and Neck Surgery, CUHK
N/A
Not Applicable
Ms. Kit Chan
Room 84026, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong
3505 1277
kitchan@ent.cuhk.edu.hk
Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
Hong Kong SAR
Michael Tong
Room 84026, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong
3505 1277
mtong@ent.cuhk.edu.hk
Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong
Hong Kong SAR
Audiological benefits and subjective satisfaction with adhesive bone-conduction device in conductive hearing loss patients
Audiological benefits and subjective satisfaction with adhesive bone-conduction device in conductive hearing loss patients
黏合式骨導助聽器對傳導性弱聽人士的聽力效益及用者滿意狀況
Hong Kong SAR
Yes
2018-01-24
Joint CUHK-NTEC Clinical Research Ethics Committee
2017.553
conductive hearing loss
Device
An adhesive form of bone-conduction hearing device
N/A
N/A
8 weeks of use during waking hours
N/A
No comparative treatment
N/A
N/A
N/A
N/A
Unilateral or bilateral conductive hearing loss, as defined by the affected ear(s) having bone-conduction thresholds of no worse than 25 dB(HL) at 0.5 – 4 kHz and air-bone gaps of at least 10 dB at three of the tested frequencies;
Absence of skin or scalp conditions that may preclude attachment of the adhesive adapter, or interfere with audio processor usage;
Aged 6 years and above and can comply with evaluation procedures;
Cantonese as the primary language;
Willingness to attend extra audiological sessions for evaluating device benefits;
Willingness to fill out journal regarding device usage and questionnaires regarding user satisfaction;
Willingness and being able to provide daily care to a loaned device;
Gives consent to taking part in the study.
Does not meet one or more of the inclusion criteria listed above;
Any type of hearing loss other than conductive;
Health, physical, or cognitive conditions that would interfere with the completion of, participation in, or provision of valid responses during the required audiological evaluations, or interfere with adherence to study procedures.
6 years old
999
Both Male and Female
Interventional
Not Applicable
Not Applicable
Open label
Single group
Other
Device received FDA clearance.
2018-11-01
40
Not Yet Recruiting
Change in sound-field audiometric threshold
Sound-field audiometry
Week 4, Week 8
Change in sentence reception threshold in noise
Cantonese Hearing In Noise Test (CHINT)
Week 4, Week 8
Self-rated hearing qualities associated with device use
Speech, Spatial and Qualities of Hearing scale (SSQ12)
Week 4, Week 8
User experience with the adhesive bone-conduction device
ADHEAR Use and Satisfaction Questionnaire
Week 8
2018-12-05
ChiCTR1800019012
2018-10-08
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