Prospective

Dr. Kammy Yeung

Room 84026, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

3505 1277

kammyyeung@ent.cuhk.edu.hk

Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

Hong Kong

Prof. Michael Chi-Fai 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

建立寬頻聲阻抗於中國人耳朵的標準數據

Yes

2018-07-06

Joint CUHK-NTEC Clinical Research Ethics Committee

2018.212

Procedure

Wideband aural acoustic transfer function, measured using wideband tympanometry.

Not a drug trial

Not a drug trial

Less than one-minute objective testing in each ear

Once

No comparative treatment

No comparative treatment

No comparative treatment

No comparative treatment

No comparative treatment

For normative data, we plan to recruit thirty participants in 1:1 gender ratio in each of the following age groups: 3 – 5;11 years, 6 – 9;11 years, 10 – 30 years, 31 – 45 years, 46 – 60 years, 61 – 75 years, 76 years old and above; corresponding to a minimum of 210 participants. The inclusion criteria are:

1. Outpatients of the Dept. of Ear, Nose and Throat of the Prince of Wales Hospital (PWH, NTEC) who are aged 3 years and above and referred to the PWH Audiology Centre for audiological assessments;

2. Negative history of chronic middle-ear disease;

3. 226 Hz tympanometric criteria within normal limits, defined as having middle-ear compliance ≥ 0.3 ml, middle-ear pressure within +/- 100 daPa, and equivalent ear-canal volume ≤ 2.0 cm3;

4. Absence of significant air-bone gaps in the ear to be assessed, defined as having air-bone gap of no greater than 10 dB at 0.5, 1, 2, & 4 kHz;

5. No gross eardrum abnormalities or excessive cerumen as revealed via otoscopic examination, in the ear to be assessed;

6. Able to understand the consenting procedure and willing to provide written consent; for children aged under 18 years written consent will be obtained from accompanying parent or guardian.

For disease-specific data, we plan to recruit 150 adult patients meeting the following criteria:

1. Outpatients of the PWH Dept. of Ear, Nose and Throat who are aged 18 years and above and referred to the PWH Audiology Centre for audiological assessments;

2. Referral reason is middle-ear related, e.g. conductive hearing loss, otosclerosis, otitis media effusion (OME), tympanic membrane perforation, middle-ear disease;

3. Referred for standard tympanometry as well;

4. Absence of any of the exclusion criteria abovementioned for normative sample.

Adult or child who presents any of the followings will be excluded: active discharge in ear canal, swollen ear canal, atresia, failure to comply with test procedures including insertion of test probe.

3 years old

999

Both Male and Female

Not Applicable

Not Applicable

Not Applicable

Not Applicable

Other

not a drug trial

To establish Chinese normative data of wideband Energy Absorbance, which, is an emerging objective audiological measurement for revealing aural acoustic transfer function over a board frequency range.

No