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Trial Detail

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

No

2018-12-05

ChiCTR1800019012

2018-10-08

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