Optimizing Elderly Hearing Loss Care in Hong Kong A Cost-Effectiveness and Satisfactory Analysis of a Pilot Collaborative Model Between Otorhinolaryngologists and Family Medicine Specialists

August 21, 2026 updated by: YEUNG WING CHI ZENON, Tseung Kwan O Hospital, Hong Kong

This study will evaluate a new collaborative elderly hearing-loss service in Hong Kong. The service is based in Family Medicine (FM) and supported by Ear, Nose and Throat (ENT) specialist nurses and audiology services. It aims to provide earlier hearing assessment, counselling, hearing-aid referral or fitting where appropriate, and referral to ENT specialists when more complex ear problems are suspected.

The study will compare this new service with the existing ENT elderly hearing clinic. About 500 adults aged 65 years or above with progressive hearing loss will be enrolled. Researchers will compare the time to hearing assessment and hearing-related abilities and quality of life score, satisfactory score related to the care in the FM and ENT cohort, compliance to hearing aids, and referral to ENT services. The findings may help determine whether the new service is safe, cost-effective and improves access to hearing care.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Age-related hearing loss is common and can affect communication, daily activities, social participation, emotional wellbeing, and quality of life. Older adults with hearing loss may experience delays in accessing assessment and rehabilitation because demand for ENT specialist outpatient services is exceedingly high. A collaborative care pathway based in Family Medicine may allow suitable patients to receive earlier hearing assessment and rehabilitation while maintaining clear routes for referral to ENT when clinically indicated.

This prospective, parallel-cohort observational study will evaluate a new FM elderly hearing clinic at Tseung Kwan O South Family Medicine Clinic. The clinic is delivered by Family Medicine doctors with support from ENT specialist nurses and audiology services. It will be compared with the established ENT elderly hearing clinic at ENT Specialist Outpatient Clinic at Tseung Kwan O Hospital. Allocation will follow usual clinical referral, triage, and service pathways; participants will not be randomized.

Consecutive eligible patients aged 65 years or above with bilateral progressive hearing loss, earwax impaction, or a referral need for hearing aids will be invited to participate. Patients with urgent or complex otologic presentations requiring specialist care, including sudden sensorineural hearing loss, acute ear infection or otorrhoea, tympanic-membrane perforation, or suspected cholesteatoma or other serious middle-ear disease, will be excluded. Patients must be able to provide informed consent, either independently or with sufficient caregiver support to complete study questionnaires.

Approximately 500 participants will be recruited over about 12 months: approximately 100 in the FM cohort and 400 in the ENT cohort. Participants will undergo hearing assessment, including pure-tone audiometry or an equivalent assessment, and will receive care according to their assigned usual-care pathway. In the FM pathway, clinicians will assess hearing loss, provide counselling, arrange audiologic testing, facilitate hearing-aid fitting where indicated, and refer patients to ENT according to predefined escalation criteria. In the ENT pathway, participants will receive assessment and treatment through established specialist clinic and audiology protocols.

Baseline data will include demographic and clinical information, comorbidities, presenting symptoms, otologic findings, and hearing-test results. Participants will complete the traditional Chinese versions of Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12), the Older People's Quality of Life Brief questionnaire (OPQOL-Brief), the 15-item Geriatric Depression Scale (GDS-15), and a structured patient-satisfaction questionnaire. These measures will be repeated after hearing-aid fitting, where applicable, to assess changes in hearing-related function, quality of life, mood, experience of care, hearing-aid use, and adherence. Participants with a GDS-15 score of 8 or higher will be provided with information regarding mood disturbance and referred to Family Medicine for further assessment and management of possible depression.

The study will compare time from first presentation with hearing loss to first hearing assessment and, where indicated, to hearing-aid prescription. It will also compare patient-reported outcomes, satisfaction, hearing-aid compliance, clinic consultation time, and the proportion of FM-pathway patients subsequently referred to ENT. Researchers will assess changes in the volume and pattern of ENT referrals for elderly hearing loss after implementation of the FM clinic. Analyses will include an overall comparison between the FM and ENT cohorts, as well as a secondary matched comparison between the FM cohort and a similar-sized ENT subgroup with comparable age, baseline characteristics, and hearing-loss severity.

The cost-effectiveness analysis will consider the number of clinic visits before discharge, proportion of patients that require referral to ENT specialist outpatient clinic. The study is intended to assess whether this collaborative model can provide safe, satisfactory, and timely hearing rehabilitation for older adults while reducing avoidable demand on specialist ENT outpatient services.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Zenon YEUNG, MbChB (CUHK), FRCS (Edin)
Phone Number: 852-39493549
Email: zenon.yeung@ha.org.hk

Study Contact Backup

Name: Thomas SC Hui, BSc
Phone Number: +852-39493549
Email: hsc526@ha.org.hk

Study Locations

Hong Kong
- - Hong Kong, Hong Kong
    - Department of Ear, Nose and Throat at United Christian Hospital and Tseung Kwan O Hospital
    - Contact:
      
      Thomas SC Hui, BSc
      
      Phone Number: 852-39493549
      
      Email: hsc526@ha.org.hk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

The study population comprises adults aged 65 years or above presenting with hearing loss to either the new Family Medicine elderly hearing clinic at Tseung Kwan O South Family Medicine Clinic or the existing ENT elderly hearing clinic at specialist outpatient clinic at Tseung Kwan O Hospital, Hong Kong. Participants will have progressive bilateral hearing loss, hearing difficulty associated with earwax impaction, or a need for hearing-aid assessment or rehabilitation.

Approximately 500 participants will be recruited: approximately 100 participants in the Family Medicine clinic cohort and 400 participants in the ENT clinic cohort. The study excludes patients with urgent or complex otologic conditions that require prompt specialist ENT evaluation.

Description

Inclusion Criteria:

Aged 65 years or above.
Attending the Family Medicine elderly hearing clinic at Tseung Kwan O South Family Medicine Clinic or the ENT elderly hearing clinic at Specialist Outpatient Clinic at Tseung Kwan O Hospital.
Bilateral progressive hearing loss for more than 1 month without acute ear infection; or earwax impaction affecting hearing; or referred for hearing-aid assessment, prescription, fitting, or follow-up.
Able to provide written informed consent independently, or with caregiver support sufficient to facilitate completion of study questionnaires.
Adequate language proficiency, including Cantonese where applicable, to complete the validated study questionnaires.

Exclusion Criteria:

Sudden sensorineural hearing loss.
Acute otitis, otorrhoea, or other acute ear infection requiring urgent assessment.
Tympanic-membrane perforation.
Suspected cholesteatoma or other serious middle-ear disease.
Other red-flag otologic presentations requiring urgent ENT specialist evaluation.
Severe cognitive impairment that, in the clinician's judgement, prevents meaningful informed consent or completion of study questionnaires.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Family Medicine Elderly Hearing Clinic Cohort Older adults with hearing loss managed through the Family Medicine elderly hearing clinic at Tseung Kwan O South Family Medicine Clinic. Care is provided by Family Medicine doctors with support from ENT specialist nurses and audiology services, with referral to ENT according to predefined clinical escalation criteria.
ENT Elderly Hearing Clinic Cohort Older adults with hearing loss managed through the existing ENT elderly hearing clinic at the Specialist Outpatient Clinic at Tseung Kwan O Hospital, with assessment and treatment delivered according to established specialist-clinic and audiology protocols.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in hearing-related function measured by the Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12) Time Frame: Baseline to post-hearing aid fitting review, up to 24 months	Change in SSQ-12 score from baseline to follow-up. The SSQ-12 is a 12-item patient-reported measure of hearing abilities and hearing quality; higher scores indicate better self-reported hearing ability.	Baseline to post-hearing aid fitting review, up to 24 months
Change in quality of life measured by the Older People's Quality of Life Brief questionnaire (OPQOL-Brief) Time Frame: Baseline to post-hearing aid fitting review, up to 24 months	Change in OPQOL-Brief score from baseline to follow-up. The OPQOL-Brief is a 13-item patient-reported measure of quality of life in older adults; higher scores indicate better quality of life.	Baseline to post-hearing aid fitting review, up to 24 months
Change in depressive symptoms measured by the 15-item Geriatric Depression Scale (GDS-15) Time Frame: Baseline to post-hearing aid fitting review, up to 24 months	Change in GDS-15 score from baseline to follow-up. The GDS-15 is a 15-item self-report screening measure of depressive symptoms in older adults; total scores range from 0 to 15, with higher scores indicating more depressive symptoms.	Baseline to post-hearing aid fitting review, up to 24 months
Patient satisfaction with the hearing-care pathway Time Frame: Baseline to post-hearing aid fitting review, up to 24 months	Patient satisfaction score measured using the study structured satisfaction questionnaire at follow-up. Higher scores indicate greater satisfaction with the hearing-care service received.	Baseline to post-hearing aid fitting review, up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from first presentation with hearing loss to first hearing assessment and hearing rehabilitation Time Frame: Up to 12 months	Number of days from the first submission of referral for hearing loss to completion of the first hearing assessment and hearing rehabilitation, derived from Hospital Authority electronic clinical records.	Up to 12 months
Referral from the Family Medicine pathway to ENT specialist outpatient care Time Frame: Up to 24 months	Proportion of participants in the Family Medicine elderly hearing clinic cohort who are referred to ENT specialist outpatient care, together with documented reasons for referral or pathway escalation.	Up to 24 months
Hearing-aid use and adherence Time Frame: At follow-up, up to 1 year after hearing aid fitting	Proportion of participants prescribed or fitted with hearing aids who report hearing-aid use, adherence, perceived benefit, or problems at follow-up.	At follow-up, up to 1 year after hearing aid fitting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tseung Kwan O Hospital, Hong Kong

Investigators

Principal Investigator: Zenon Yeung, MbChB (CUHK), FRCS (Edin), Department of Ear, Nose and Throat, Tseung Kwan O Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

August 12, 2026

First Submitted That Met QC Criteria

August 21, 2026

First Posted (Actual)

August 24, 2026

Study Record Updates

Last Update Posted (Actual)