Hearing Loss, Age-RelatedNCT07782177
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
An observational study of Hearing Loss, Age-Related and Presbycusis, run by Tseung Kwan O Hospital, Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hearing Loss, Age-Related, Presbycusis
- How many people
- 500 participants
- Where
- 1 siteHong Kong
- Study dates
- Sep 2026to Aug 2028
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
Department of Ear, Nose and Throat at United Christian Hospital and Tseung Kwan O Hospital
Hong Kong
Thomas SC Hui, BSc, 852-39493549, hsc526@ha.org.hk
About this study
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.
Read the 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.
- Conditions
- Hearing Loss, Age-Related, Presbycusis
- Keywords
- Hearing Loss, Presbycusis, Age-related Hearing Loss, Hearing rehabilitation, Primary care, Family Medicine, Otolaryngology, Nurse-led clinic, Health services research
- Medical subject headings
- Presbycusis, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Change in hearing-related function measured by the Speech, Spatial and Qualities of Hearing Scale-12 (SSQ-12)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline to post-hearing aid fitting review, up to 24 months
Patient satisfaction with the hearing-care pathway
Patient satisfaction score measured using the study structured satisfaction questionnaire at follow-up. Higher scores indicate greater satisfaction with the hearing-care service received.
Measured: Baseline to post-hearing aid fitting review, up to 24 months
Secondary outcomes (3)
Time from first presentation with hearing loss to first hearing assessment and hearing rehabilitation
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.
Measured: Up to 12 months
Referral from the Family Medicine pathway to ENT specialist outpatient care
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.
Measured: Up to 24 months
Hearing-aid use and adherence
Proportion of participants prescribed or fitted with hearing aids who report hearing-aid use, adherence, perceived benefit, or problems at follow-up.
Measured: At follow-up, up to 1 year after hearing aid fitting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, Age-RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Tseung Kwan O Hospital, Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YEUNG WING CHI ZENON, Tseung Kwan O Hospital, Hong Kong
- Investigators
- Zenon Yeung, MbChB (CUHK), FRCS (Edin), Principal investigator, Department of Ear, Nose and Throat, Tseung Kwan O Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07782177
- Sponsor's protocol ID
- TseungKwanOH
- Status last verified
- Aug 2026
- First submitted
- 12 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Friedmann DR, Diminich LN, Spitzer ER, Ajmal S, Weinstein B, Dickson V, Goldfeld KS, Chodosh J. Study protocol: feasibility of a hearing program in primary care for underserved older adults. Pilot Feasibility Stud. 2026 Feb 24;12(1):68. doi: 10.1186/s40814-026-01773-2.
PubMed 41736137Bennett RJ, Fletcher S, Conway N, Barr C. The role of the general practitioner in managing age-related hearing loss: perspectives of general practitioners, patients and practice staff. BMC Fam Pract. 2020 May 14;21(1):87. doi: 10.1186/s12875-020-01157-2.
PubMed 32410580Manrique-Huarte R, Calavia D, Huarte Irujo A, Giron L, Manrique-Rodriguez M. Treatment for Hearing Loss among the Elderly: Auditory Outcomes and Impact on Quality of Life. Audiol Neurootol. 2016;21 Suppl 1:29-35. doi: 10.1159/000448352. Epub 2016 Nov 3.
PubMed 27806353Easton G, Leverton T. Supporting adults with hearing loss in primary care: new NICE guideline. Br J Gen Pract. 2018 Nov;68(676):516-517. doi: 10.3399/bjgp18X699497. No abstract available.
PubMed 30361304Ying G, Zhao G, Xu X, Su S, Xie X. Association of age-related hearing loss with cognitive impairment and dementia: an umbrella review. Front Aging Neurosci. 2023 Sep 18;15:1241224. doi: 10.3389/fnagi.2023.1241224. eCollection 2023.
PubMed 37790283Thomson RS, Auduong P, Miller AT, Gurgel RK. Hearing loss as a risk factor for dementia: A systematic review. Laryngoscope Investig Otolaryngol. 2017 Mar 16;2(2):69-79. doi: 10.1002/lio2.65. eCollection 2017 Apr.
PubMed 28894825Loughrey DG, Kelly ME, Kelley GA, Brennan S, Lawlor BA. Association of Age-Related Hearing Loss With Cognitive Function, Cognitive Impairment, and Dementia: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Feb 1;144(2):115-126. doi: 10.1001/jamaoto.2017.2513.
PubMed 29222544Liu CM, Lee CT. Association of Hearing Loss With Dementia. JAMA Netw Open. 2019 Jul 3;2(7):e198112. doi: 10.1001/jamanetworkopen.2019.8112.
PubMed 31365110Cantuaria ML, Pedersen ER, Waldorff FB, Wermuth L, Pedersen KM, Poulsen AH, Raaschou-Nielsen O, Sorensen M, Schmidt JH. Hearing Loss, Hearing Aid Use, and Risk of Dementia in Older Adults. JAMA Otolaryngol Head Neck Surg. 2024 Feb 1;150(2):157-164. doi: 10.1001/jamaoto.2023.3509.
PubMed 38175662Lizaur-Utrilla A, Martinez-Mendez D, Miralles-Munoz FA, Marco-Gomez L, Lopez-Prats FA. Negative impact of waiting time for primary total knee arthroplasty on satisfaction and patient-reported outcome. Int Orthop. 2016 Nov;40(11):2303-2307. doi: 10.1007/s00264-016-3209-0. Epub 2016 Apr 28.
PubMed 27121844Sprinzl GM, Riechelmann H. Current trends in treating hearing loss in elderly people: a review of the technology and treatment options - a mini-review. Gerontology. 2010;56(3):351-8. doi: 10.1159/000275062. Epub 2010 Jan 12.
PubMed 20090297Yueh B, Shapiro N, MacLean CH, Shekelle PG. Screening and management of adult hearing loss in primary care: scientific review. JAMA. 2003 Apr 16;289(15):1976-85. doi: 10.1001/jama.289.15.1976.
PubMed 12697801
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07782177
- Acronym / sponsor ID
- TseungKwanOH
- Conditions
- Hearing Loss, Age-Related, Presbycusis
- Keywords
- Hearing Loss, Presbycusis, Age-related Hearing Loss, Hearing rehabilitation, Primary care, Family Medicine, Otolaryngology, Nurse-led clinic
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tseung Kwan O Hospital, Hong KongUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Time from first presentation with hearing loss to first hearing assessment and hearing rehabilitation
Time frame: Up to 12 months
Referral from the Family Medicine pathway to ENT specialist outpatient care
Time frame: Up to 24 months
Hearing-aid use and adherence
Time frame: At follow-up, up to 1 year after hearing aid fitting
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 41736137Friedmann DR, Diminich LN, Spitzer ER, Ajmal S, Weinstein B, Dickson V, Goldfeld KS, Chodosh J. Study protocol: feasibility of a hearing program in primary care for underserved older adults. Pilot Feasibility Stud. 2026 Feb 24;12(1):68. doi: 10.1186/s40814-026-01773-2.
- Background: PubMed 32410580Bennett RJ, Fletcher S, Conway N, Barr C. The role of the general practitioner in managing age-related hearing loss: perspectives of general practitioners, patients and practice staff. BMC Fam Pract. 2020 May 14;21(1):87. doi: 10.1186/s12875-020-01157-2.
- Background: PubMed 27806353Manrique-Huarte R, Calavia D, Huarte Irujo A, Giron L, Manrique-Rodriguez M. Treatment for Hearing Loss among the Elderly: Auditory Outcomes and Impact on Quality of Life. Audiol Neurootol. 2016;21 Suppl 1:29-35. doi: 10.1159/000448352. Epub 2016 Nov 3.
- Background: PubMed 30361304Easton G, Leverton T. Supporting adults with hearing loss in primary care: new NICE guideline. Br J Gen Pract. 2018 Nov;68(676):516-517. doi: 10.3399/bjgp18X699497. No abstract available.
- Background: PubMed 37790283Ying G, Zhao G, Xu X, Su S, Xie X. Association of age-related hearing loss with cognitive impairment and dementia: an umbrella review. Front Aging Neurosci. 2023 Sep 18;15:1241224. doi: 10.3389/fnagi.2023.1241224. eCollection 2023.
- Background: PubMed 28894825Thomson RS, Auduong P, Miller AT, Gurgel RK. Hearing loss as a risk factor for dementia: A systematic review. Laryngoscope Investig Otolaryngol. 2017 Mar 16;2(2):69-79. doi: 10.1002/lio2.65. eCollection 2017 Apr.
- Background: PubMed 29222544Loughrey DG, Kelly ME, Kelley GA, Brennan S, Lawlor BA. Association of Age-Related Hearing Loss With Cognitive Function, Cognitive Impairment, and Dementia: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Feb 1;144(2):115-126. doi: 10.1001/jamaoto.2017.2513.
- Background: PubMed 31365110Liu CM, Lee CT. Association of Hearing Loss With Dementia. JAMA Netw Open. 2019 Jul 3;2(7):e198112. doi: 10.1001/jamanetworkopen.2019.8112.
- Background: PubMed 38175662Cantuaria ML, Pedersen ER, Waldorff FB, Wermuth L, Pedersen KM, Poulsen AH, Raaschou-Nielsen O, Sorensen M, Schmidt JH. Hearing Loss, Hearing Aid Use, and Risk of Dementia in Older Adults. JAMA Otolaryngol Head Neck Surg. 2024 Feb 1;150(2):157-164. doi: 10.1001/jamaoto.2023.3509.
- Background: PubMed 27121844Lizaur-Utrilla A, Martinez-Mendez D, Miralles-Munoz FA, Marco-Gomez L, Lopez-Prats FA. Negative impact of waiting time for primary total knee arthroplasty on satisfaction and patient-reported outcome. Int Orthop. 2016 Nov;40(11):2303-2307. doi: 10.1007/s00264-016-3209-0. Epub 2016 Apr 28.
- Background: PubMed 20090297Sprinzl GM, Riechelmann H. Current trends in treating hearing loss in elderly people: a review of the technology and treatment options - a mini-review. Gerontology. 2010;56(3):351-8. doi: 10.1159/000275062. Epub 2010 Jan 12.
- Background: PubMed 12697801Yueh B, Shapiro N, MacLean CH, Shekelle PG. Screening and management of adult hearing loss in primary care: scientific review. JAMA. 2003 Apr 16;289(15):1976-85. doi: 10.1001/jama.289.15.1976.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zenon Yeung, MbChB (CUHK), FRCS (Edin) principal investigator
Department of Ear, Nose and Throat, Tseung Kwan O Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, Age-Related and Presbycusis, run by Tseung Kwan O Hospital, Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zenon YEUNG, MbChB (CUHK), FRCS (Edin) (852-39493549, zenon.yeung@ha.org.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07782177, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.