Sensorineural Hearing LossHAHANCT06495268
Healthy heaAring for Healthy Ageing: Data-driven Hearing Rehabilitation Intervention to Promote Healthy Hearing
A study testing Individualised data-driven hearing rehabilitation in people with Sensorineural Hearing Loss and Cognitive Decline, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
The goal of the HAHA trial is to prove that the treatment of HI and prevention of HI-related cognitive decline are most likely to be effective if HI is approached as a broader neurodegenerative entity with multifaceted manifestations currently unaddressed in clinical practice and managed using a novel individualised… Read more about this study
- Who is it for?
- Ages 65 to 84 years
- Conditions the study is for
- Sensorineural Hearing Loss, Cognitive Decline
- What is being tested?
- Individualised data-driven hearing rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- 1 Oct 2024to 29 Feb 2028
- Phase
- Interventional
- 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 to 84 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Mild to moderately severe sensorineural HI (PTA (0,5-4kHz) between 20-64 dB (HL), as per Global Burden of Disease Expert Group on Hearing loss criteria)
- Community-dwelling, i.e. living at home / not living in a care home or nursing home
- Proficiency in Finnish language
- First-time hearing aid user
Who cannot join
- Conductive hearing loss (air-bone gap more than 20 dB HL in two consecutive frequencies)
- Difference between hearing levels of the ears is more than 15dB (HL) in three consecutive frequencies
- Hearing aid contraindication
- Previously diagnosed dementia, or current use of cholinesterase inhibitors and/or memantine. If there is a current ongoing diagnostic process for suspected dementia, the decision on eligibility will be made by an experienced study physician based on medical records and clinical judgement.
- Any health conditions severely impairing vision, mobility, communication, and/or ability to participate in study visits and complete study assessments, as judged by the study nurse and/or physician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Healthy Hearing for Healthy Ageing: a Proof-of-concept Randomized Controlled Trial of Data-driven Hearing Rehabilitation Versus Standard Care in Older Adults With Hearing Impairment.
The goal of the HAHA trial is to prove that the treatment of HI and prevention of HI-related cognitive decline are most likely to be effective if HI is approached as a broader neurodegenerative entity with multifaceted manifestations currently unaddressed in clinical practice and managed using a novel individualised data-driven protocol for early hearing rehabilitation. The main hypothesis is that, compared with standard care, the data-driven rehabilitation will likely have broader benefits manifested in three key areas: hearing, cognition, and quality of life and psychosocial outcomes.
Participants will be randomized 1:1 to either intervention (individualised data-driven hearing rehabilitation) or control group (standard care hearing rehabilitation). The primary objective of this study is to investigate the effect of an optimized data-driven hearing rehabilitation protocol versus standard care protocol on change in speech perception in noise (SPIN) in older adults with mild to moderately severe sensorineural HI and without dementia.
Read the detailed description
Hearing impairment (HI) is a major public health problem. HI has also been identified as a significant potentially modifiable risk factor for dementia. Thus, hearing rehabilitation may contribute to dementia risk reduction, although a causal HI-dementia relation is not fully established.
The HAHA trial will test an individualised, data-driven hearing rehabilitation protocol based on the ongoing BREM (Benefits of Real-Ear Measurement) study at KUH (clinicaltrials.gov ID NCT05621798). HAHA will use a pragmatic approach incorporated into routine specialized care (Hearing Center at the Dept of Otorhinolaryngology of KUH), to facilitate optimisation of the current HI clinical pathway and treatment process. This study is a proof-of-concept, single-site, 2-arm parallel group 12-month randomized controlled trial with a 12-month extended follow-up.
The investigators will recruite 200 participants referred to the Kuopio University Hospital Hearing Center from primary care that are aged 65 to 84 years with mild to moderately severe sensorineural HI and are about to receive their first HAs.
The intervention group will receive individually fitted HAs based on preliminary results from the ongoing BREM study at KUH to ensure adequate amplification, with immediate SPIN-based benefit validation. HA selection and individual tailoring will also be based on hearing questionnaires data. Participants are invited to intervention-related monitoring appointments at 3, 6 and 12 months after the primary HA fitting.
The control group will receive the same HAs fitted according to the standard care protocol. Standard care follow-up includes a phone call check 3 months after the primary fitting. Additional monitoring/re-fitting may be offered based on the participant's feedback and hearing rehabilitator's clinical judgement.
A range of auditory, cognitive, quality of life and psychosocial measures as well as exploratory measures such as EEG, MRI and vision-related measures are assessed at 12-month and 24-month visits on both groups. These assessments are included to investigate potential mechanisms underlying associations between HI, hearing rehabilitation, vision and cognition. The overall duration of the this trial is 2 years.
- Conditions
- Sensorineural Hearing Loss, Cognitive Decline
- Being tested
- Individualised data-driven hearing rehabilitation, Standard care hearing rehabilitation
- Keywords
- Hearing Impairment, Hearing Rehabilitation, Hearing Loss, Cognition, Data-driven rehabilitation
- Medical subject headings
- Hearing Loss, Sensorineural, Cognitive Dysfunction, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualised data-driven hearing rehabilitationOther
HA fittings will be conducted with the Real-Ear Measurements (REM) method that is recommended by the latest ISO-standard (21388:2020) and by the preliminary results of the BREM study at KUH. After the fitting of the HAs, participants' auditory-related outcomes will be immediately assessed using DigiKuulo and re-fitting is performed if needed based on the following criteria:
- The absolute improvement in the DIN test is less than 1,5dB (SNR), OR
- The absolute result of the DIN test is more than -8,5 dB (SNR) OR
- The participant is unsatisfied with the HA fitting
Participants are invited to intervention-related monitoring appointments at 3, 6 and 12 months after the primary HA fitting. At these visits, auditory outcomes of the rehabilitation are assessed via DigiKuulo and re-fittings are performed as needed.
Standard care hearing rehabilitationOther
HA will be fitted with automatic algorithms by HA manufacturers and REM-fitting is only applied in complex cases based on the hearing rehabilitator's clinical judgement. Three months after the HA fitting, participants will be contacted via phone call to inquire about the status of the rehabilitation. Additional monitoring visits may be offered based on the participant's feedback. After the 3-month monitoring phone call participants will be advised to further contact the study team if they are dissatisfied with the amplification or for any other problem with their device.
| Study group | Role | What they receive |
|---|---|---|
| Individualised data-driven hearing rehabilitation | Active comparator | Participants in the intervention group will receive data-driven, regularly controlled hearing aid rehabilitation that is not part of the standard care protocol. Receives: Other: Individualised data-driven hearing rehabilitation |
| Standard care hearing rehabilitation | Active comparator | The participants in the control group will receive the standard care HA rehabilitation currently conducted at the KUH Hearing Center. Receives: Other: Standard care hearing rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finnish Matrix Sentence Test (FMST)
A Speech-in-Noise test, validated for the Finnish language. In the test participants will listen to five-word sentences chosen out of a standardized and optimized word matrix under stationary background noise (65dB SPL). The result of the FMST is the signal-to-noise ratio (SNR) at which the participant identifies 50% of the presented word items correctly, this is called the speech reception threshold (SRT50).
Measured: Change measures: 0 months, 12 months, 24 months
Digits in Noise test (DIN)
A Speech-in-Noise test, validated for the Finnish language. The word material of the test consists of digit triplets presented under stationary background noise (65dB SPL). The result of the DIN is the signal-to-noise ratio at which the participant identifies 50% of the presented triplets correctly, this is called the speech reception threshold (SRT50).
Measured: Change measures: 0 months, 12 months, 24 months
Secondary outcomes (11)
Speech, Spatial and Quality questionnaires - SSQ
The SSQ questionnaire is a self-reporting hearing questionnaire that comprises 49 questions divided into three subdomains: Speech Perception (SP), Spatial Hearing (SH) and other qualities of Hearing (SQ) (18). The answers are provided on an 11-point Likert scale, ranging from 0 to 10.
Measured: Change measures: 0 months, 12 months, 24 months
Hearing aid usage (self-report and HAs log data)
Usage rates of HAs (hours per day) are regularly checked via the HAs' log-data source and recorded during every clinical visit. In addition, participants' own estimation of usage rates is inquired and recorded.
Measured: Change measures: 0 months, 12 months, 24 months
Listening effort questionnaire
Listening effort will be self-reported by the participant for listening tasks of varying difficulties (i.e., different signal-to-noise ratios) on a 10-point VAS scale.
Measured: Change measures: 0 months, 12 months, 24 months
Response time (DIN test)
Response time for the answers given by the participant will be calculated and recorded automatically
Measured: Change measures: 0 months, 12 months, 24 months
Tinnitus Handicap Inventory (THI)
The THI is a 25-item self-report questionnaire for tinnitus that has Functional, Emotional and Catastrophic subscales. It has excellent convergent validity, construct validity and test-retest reliability. The THI takes 10min to complete. Scoring takes 5 min with a score of 4 for a 'yes', 2 for 'sometimes' and 0 for 'no'.
Measured: Change measures: 0 months, 12 months, 24 months
CERAD-nb (global and domain scores)
The Finnish version of the CERAD (Consortium to Establish a Registry for Alzheimer´s Disease) test battery is recommended for assessment of memory disorders in the national Current Care Guidelines developed by the Finnish Medical Society Duodecim (www.kaypahoito.fi).
Measured: Change measures: 0 months, 12 months, 24 months
Clinical Dementia Rating Sum of Boxes (CDR-SoB)
CDR (Clinical Dementia Rating) is used to assess the influence of cognitive impairment on the ability to conduct everyday activities in people with AD and gives a global clinical impression of the functioning level of the study participant. The assessor will interview the participant regarding their cognitive performance on six domains: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on level of impairment: 0 (none), 0.5 (questionable), 1 (mild dementia), 2 (moderate dementia) or 3 (severe dementia). The total Sum of Boxes ranges from 0 (no impairment) to 18 (severe impairment on all domains).
Measured: Change measures: 0 months, 12 months, 24 months
15D questionnaire
A generic, comprehensive, standardized, self-administered questionnaire of health-related quality of life developed in Finland. It includes 15 questions providing a numerical score for patient-perceived health status. It can be used both as a profile and single index score measure. It is commonly used in Finland to assess quality of life in standard care.
Measured: Change measures: 0 months, 12 months, 24 months
EQ5-D-5L questionnaire
A concise, generic measure of self-reported health which is accompanied by weights reflecting the relative importance to people of different types of health problems
Measured: Change measures: 0 months, 12 months, 24 months
Beck Depression Inventory (BDI)
A short, self-administered questionnaire to quantify psychological and physical symptoms of depression. It includes 21 items, and participants are asked to rate each item using a 4-point Likert scale. The BDI is one of the most frequently used questionnaires for the assessment of depression in clinical practice, including in older adults.
Measured: Change measures: 0 months, 12 months, 24 months
Hearing in real-life environment - HERE
The HERE questionnaire is self-reporting hearing questionnaire validated in Finnish language (28). It includes 15 items with a numeric rating scale from 0 to 10 for each item and allows the assessment of hearing with and without hearing aids.
Measured: Change measures: 0 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start1 Oct 2024
- Primary completion29 Feb 2028 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Sensorineural Hearing LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to either intervention (individualised data-driven hearing rehabilitation) or control group (standard care hearing rehabilitation) by computer-generated allocation in blocks of four (two individuals randomly allocated to each group). The intervention group will receive individually fitted HAs with immediate SPIN-based benefit validation. HA selection and individual tailoring will also be based on hearing questionnaires data. Participants are invited to intervention-related monitoring appointments at 3, 6 and 12 months. The control group will receive the same HAs fitted according to the standard care protocol. Standard care follow-up includes a phone call check 3 months after the primary fitting. Additional monitoring/re-fitting may be offered based on the participant's feedback and hearing rehabilitator's clinical judgement. 12-month and 24-months follow-up appointments are arranged for both groups.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Responsible party
- Sponsor
- Investigators
- Aarno Dietz, prof., Principal investigator, Kuopio University Hospital and University of Eastern FinlandAlina Solomon, prof., Principal investigator, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495268
- Sponsor's protocol ID
- KUH5551893
- Acronym
- HAHA
- Status last verified
- Feb 2026
- First submitted
- 2 Jul 2024
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The HAHA Steering Committee and Management Group are open to requests from external researchers for data collected in this study. Applicants will be asked to submit a study protocol, including the research question, planned analysis, and data required. Committee will evaluate this plan (i.e., relevance of the research question, suitability of data, quality of proposed analyses, planned/ongoing HAHA analyses, and other matters) on a case-by-case basis and provide the data or reject the request. Shared data will encompass the data dictionary and de-identified data only. Any analysis will be conducted in collaboration with the HAHA Management Group. Access is subject to the HAHA legal framework. An access agreement will be prepared and signed by both parties.
Publications
GBD 2019 Hearing Loss Collaborators. Hearing loss prevalence and years lived with disability, 1990-2019: findings from the Global Burden of Disease Study 2019. Lancet. 2021 Mar 13;397(10278):996-1009. doi: 10.1016/S0140-6736(21)00516-X.
PubMed 33714390Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available.
PubMed 32738937Brewster KK, Deal JA, Lin FR, Rutherford BR. Considering hearing loss as a modifiable risk factor for dementia. Expert Rev Neurother. 2022 Sep;22(9):805-813. doi: 10.1080/14737175.2022.2128769. Epub 2022 Sep 27.
PubMed 36150235Sanders ME, Kant E, Smit AL, Stegeman I. The effect of hearing aids on cognitive function: A systematic review. PLoS One. 2021 Dec 31;16(12):e0261207. doi: 10.1371/journal.pone.0261207. eCollection 2021.
PubMed 34972121Lin MY, Gutierrez PR, Stone KL, Yaffe K, Ensrud KE, Fink HA, Sarkisian CA, Coleman AL, Mangione CM; Study of Osteoporotic Fractures Research Group. Vision impairment and combined vision and hearing impairment predict cognitive and functional decline in older women. J Am Geriatr Soc. 2004 Dec;52(12):1996-2002. doi: 10.1111/j.1532-5415.2004.52554.x.
PubMed 15571533Gadkaree SK, Sun DQ, Li C, Lin FR, Ferrucci L, Simonsick EM, Agrawal Y. Does Sensory Function Decline Independently or Concomitantly with Age? Data from the Baltimore Longitudinal Study of Aging. J Aging Res. 2016;2016:1865038. doi: 10.1155/2016/1865038. Epub 2016 Sep 27.
PubMed 27774319Hong T, Mitchell P, Burlutsky G, Liew G, Wang JJ. Visual Impairment, Hearing Loss and Cognitive Function in an Older Population: Longitudinal Findings from the Blue Mountains Eye Study. PLoS One. 2016 Jan 25;11(1):e0147646. doi: 10.1371/journal.pone.0147646. eCollection 2016.
PubMed 26808979Brenowitz WD, Kaup AR, Lin FR, Yaffe K. Multiple Sensory Impairment Is Associated With Increased Risk of Dementia Among Black and White Older Adults. J Gerontol A Biol Sci Med Sci. 2019 May 16;74(6):890-896. doi: 10.1093/gerona/gly264.
PubMed 30452551Campbell J, Sharma A. Cross-modal re-organization in adults with early stage hearing loss. PLoS One. 2014 Feb 28;9(2):e90594. doi: 10.1371/journal.pone.0090594. eCollection 2014.
PubMed 24587400Tarawneh HY, Menegola HK, Peou A, Tarawneh H, Jayakody DMP. Central Auditory Functions of Alzheimer's Disease and Its Preclinical Stages: A Systematic Review and Meta-Analysis. Cells. 2022 Mar 16;11(6):1007. doi: 10.3390/cells11061007.
PubMed 35326458Davis A, Smith P, Ferguson M, Stephens D, Gianopoulos I. Acceptability, benefit and costs of early screening for hearing disability: a study of potential screening tests and models. Health Technol Assess. 2007 Oct;11(42):1-294. doi: 10.3310/hta11420.
PubMed 17927921Timmer BHB, Hickson L, Launer S. Do Hearing Aids Address Real-World Hearing Difficulties for Adults With Mild Hearing Impairment? Results From a Pilot Study Using Ecological Momentary Assessment. Trends Hear. 2018 Jan-Dec;22:2331216518783608. doi: 10.1177/2331216518783608.
PubMed 29956590Wright D, Gagne JP. Acclimatization to Hearing Aids by Older Adults. Ear Hear. 2021 Jan/Feb;42(1):193-205. doi: 10.1097/AUD.0000000000000913.
PubMed 32769437Panza F, Lozupone M, Solfrizzi V, Sardone R, Dibello V, Di Lena L, D'Urso F, Stallone R, Petruzzi M, Giannelli G, Quaranta N, Bellomo A, Greco A, Daniele A, Seripa D, Logroscino G. Different Cognitive Frailty Models and Health- and Cognitive-related Outcomes in Older Age: From Epidemiology to Prevention. J Alzheimers Dis. 2018;62(3):993-1012. doi: 10.3233/JAD-170963.
PubMed 29562543Yeo BSY, Song HJJMD, Toh EMS, Ng LS, Ho CSH, Ho R, Merchant RA, Tan BKJ, Loh WS. Association of Hearing Aids and Cochlear Implants With Cognitive Decline and Dementia: A Systematic Review and Meta-analysis. JAMA Neurol. 2023 Feb 1;80(2):134-141. doi: 10.1001/jamaneurol.2022.4427.
PubMed 36469314
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Hearing for Healthy Ageing: a Proof-of-concept Randomized Controlled Trial of Data-driven Hearing Rehabilitation Versus Standard Care in Older Adults With Hearing Impairment.
- ClinicalTrials.gov ID
- NCT06495268
- Acronym / sponsor ID
- HAHA / KUH5551893
- Conditions
- Sensorineural Hearing Loss, Cognitive Decline
- Keywords
- Hearing Impairment, Hearing Rehabilitation, Hearing Loss, Cognition, Data-driven rehabilitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 29 Feb 2028 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 10 Jul 2024 (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.
The goal of the HAHA trial is to prove that the treatment of HI and prevention of HI-related cognitive decline are most likely to be effective if HI is approached as a broader neurodegenerative entity with multifaceted manifestations currently unaddressed in clinical practice and managed using a novel individualised data-driven protocol for early hearing rehabilitation. The main hypothesis is that, compared with standard care, the data-driven rehabilitation will likely have broader benefits manifested in three key areas: hearing, cognition, and quality of life and psychosocial outcomes.
Participants will be randomized 1:1 to either intervention (individualised data-driven hearing rehabilitation) or control group (standard care hearing rehabilitation). The primary objective of this study is to investigate the effect of an optimized data-driven hearing rehabilitation protocol versus standard care protocol on change in speech perception in noise (SPIN) in older adults with mild to moderately severe sensorineural HI and without dementia.
Detailed description
Hearing impairment (HI) is a major public health problem. HI has also been identified as a significant potentially modifiable risk factor for dementia. Thus, hearing rehabilitation may contribute to dementia risk reduction, although a causal HI-dementia relation is not fully established.
The HAHA trial will test an individualised, data-driven hearing rehabilitation protocol based on the ongoing BREM (Benefits of Real-Ear Measurement) study at KUH (clinicaltrials.gov ID NCT05621798). HAHA will use a pragmatic approach incorporated into routine specialized care (Hearing Center at the Dept of Otorhinolaryngology of KUH), to facilitate optimisation of the current HI clinical pathway and treatment process. This study is a proof-of-concept, single-site, 2-arm parallel group 12-month randomized controlled trial with a 12-month extended follow-up.
The investigators will recruite 200 participants referred to the Kuopio University Hospital Hearing Center from primary care that are aged 65 to 84 years with mild to moderately severe sensorineural HI and are about to receive their first HAs.
The intervention group will receive individually fitted HAs based on preliminary results from the ongoing BREM study at KUH to ensure adequate amplification, with immediate SPIN-based benefit validation. HA selection and individual tailoring will also be based on hearing questionnaires data. Participants are invited to intervention-related monitoring appointments at 3, 6 and 12 months after the primary HA fitting.
The control group will receive the same HAs fitted according to the standard care protocol. Standard care follow-up includes a phone call check 3 months after the primary fitting. Additional monitoring/re-fitting may be offered based on the participant's feedback and hearing rehabilitator's clinical judgement.
A range of auditory, cognitive, quality of life and psychosocial measures as well as exploratory measures such as EEG, MRI and vision-related measures are assessed at 12-month and 24-month visits on both groups. These assessments are included to investigate potential mechanisms underlying associations between HI, hearing rehabilitation, vision and cognition. The overall duration of the this trial is 2 years.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to either intervention (individualised data-driven hearing rehabilitation) or control group (standard care hearing rehabilitation) by computer-generated allocation in blocks of four (two individuals randomly allocated to each group). The intervention group will receive individually fitted HAs with immediate SPIN-based benefit validation. HA selection and individual tailoring will also be based on hearing questionnaires data. Participants are invited to intervention-related monitoring appointments at 3, 6 and 12 months. The control group will receive the same HAs fitted according to the standard care protocol. Standard care follow-up includes a phone call check 3 months after the primary fitting. Additional monitoring/re-fitting may be offered based on the participant's feedback and hearing rehabilitator's clinical judgement. 12-month and 24-months follow-up appointments are arranged for both groups.
| Arm | Type | Receives |
|---|---|---|
| Individualised data-driven hearing rehabilitation | Active comparator | Other: Individualised data-driven hearing rehabilitationParticipants in the intervention group will receive data-driven, regularly controlled hearing aid rehabilitation that is not part of the standard care protocol. |
| Standard care hearing rehabilitation | Active comparator | Other: Standard care hearing rehabilitationThe participants in the control group will receive the standard care HA rehabilitation currently conducted at the KUH Hearing Center. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Mild to moderately severe sensorineural HI (PTA (0,5-4kHz) between 20-64 dB (HL), as per Global Burden of Disease Expert Group on Hearing loss criteria)
- Community-dwelling, i.e. living at home / not living in a care home or nursing home
- Proficiency in Finnish language
- First-time hearing aid user
Key exclusion criteria (5 listed)
- Conductive hearing loss (air-bone gap more than 20 dB HL in two consecutive frequencies)
- Difference between hearing levels of the ears is more than 15dB (HL) in three consecutive frequencies
- Hearing aid contraindication
- Previously diagnosed dementia, or current use of cholinesterase inhibitors and/or memantine. If there is a current ongoing diagnostic process for suspected dementia, the decision on eligibility will be made by an experienced study physician based on medical records and clinical judgement.
- Any health conditions severely impairing vision, mobility, communication, and/or ability to participate in study visits and complete study assessments, as judged by the study nurse and/or physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualised data-driven hearing rehabilitationHA fittings will be conducted with the Real-Ear Measurements (REM) method that is recommended by the latest ISO-standard (21388:2020) and by the preliminary results of the BREM study at KUH. After the fitting of the HAs, participants' auditory-related outcomes will be immediately assessed using DigiKuulo and re-fitting is performed if needed based on the following criteria: 1. The absolute improvement in the DIN test is less than 1,5dB (SNR), OR 2. The absolute result of the DIN test is more than -8,5 dB (SNR) OR 3. The participant is unsatisfied with the HA fitting Participants are invited to intervention-related monitoring appointments at 3, 6 and 12 months after the primary HA fitting. At these visits, auditory outcomes of the rehabilitation are assessed via DigiKuulo and re-fittings are performed as needed. | Other | Individualised data-driven hearing rehabilitation |
| Standard care hearing rehabilitationHA will be fitted with automatic algorithms by HA manufacturers and REM-fitting is only applied in complex cases based on the hearing rehabilitator's clinical judgement. Three months after the HA fitting, participants will be contacted via phone call to inquire about the status of the rehabilitation. Additional monitoring visits may be offered based on the participant's feedback. After the 3-month monitoring phone call participants will be advised to further contact the study team if they are dissatisfied with the amplification or for any other problem with their device. | Other | Standard care hearing rehabilitation |
Primary outcome
Finnish Matrix Sentence Test (FMST)
Time frame: Change measures: 0 months, 12 months, 24 months
A Speech-in-Noise test, validated for the Finnish language. In the test participants will listen to five-word sentences chosen out of a standardized and optimized word matrix under stationary background noise (65dB SPL). The result of the FMST is the signal-to-noise ratio (SNR) at which the participant identifies 50% of the presented word items correctly, this is called the speech reception threshold (SRT50).
Digits in Noise test (DIN)
Time frame: Change measures: 0 months, 12 months, 24 months
A Speech-in-Noise test, validated for the Finnish language. The word material of the test consists of digit triplets presented under stationary background noise (65dB SPL). The result of the DIN is the signal-to-noise ratio at which the participant identifies 50% of the presented triplets correctly, this is called the speech reception threshold (SRT50).
11 secondary outcomes
Speech, Spatial and Quality questionnaires - SSQ
Time frame: Change measures: 0 months, 12 months, 24 months
Hearing aid usage (self-report and HAs log data)
Time frame: Change measures: 0 months, 12 months, 24 months
Listening effort questionnaire
Time frame: Change measures: 0 months, 12 months, 24 months
Response time (DIN test)
Time frame: Change measures: 0 months, 12 months, 24 months
Tinnitus Handicap Inventory (THI)
Time frame: Change measures: 0 months, 12 months, 24 months
CERAD-nb (global and domain scores)
Time frame: Change measures: 0 months, 12 months, 24 months
Clinical Dementia Rating Sum of Boxes (CDR-SoB)
Time frame: Change measures: 0 months, 12 months, 24 months
15D questionnaire
Time frame: Change measures: 0 months, 12 months, 24 months
EQ5-D-5L questionnaire
Time frame: Change measures: 0 months, 12 months, 24 months
Beck Depression Inventory (BDI)
Time frame: Change measures: 0 months, 12 months, 24 months
Hearing in real-life environment - HERE
Time frame: Change measures: 0 months, 12 months, 24 months
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 4 Mar 2026.
- Background: PubMed 33714390GBD 2019 Hearing Loss Collaborators. Hearing loss prevalence and years lived with disability, 1990-2019: findings from the Global Burden of Disease Study 2019. Lancet. 2021 Mar 13;397(10278):996-1009. doi: 10.1016/S0140-6736(21)00516-X.
- Background: PubMed 32738937Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available.
- Background: PubMed 36150235Brewster KK, Deal JA, Lin FR, Rutherford BR. Considering hearing loss as a modifiable risk factor for dementia. Expert Rev Neurother. 2022 Sep;22(9):805-813. doi: 10.1080/14737175.2022.2128769. Epub 2022 Sep 27.
- Background: PubMed 34972121Sanders ME, Kant E, Smit AL, Stegeman I. The effect of hearing aids on cognitive function: A systematic review. PLoS One. 2021 Dec 31;16(12):e0261207. doi: 10.1371/journal.pone.0261207. eCollection 2021.
- Background: PubMed 15571533Lin MY, Gutierrez PR, Stone KL, Yaffe K, Ensrud KE, Fink HA, Sarkisian CA, Coleman AL, Mangione CM; Study of Osteoporotic Fractures Research Group. Vision impairment and combined vision and hearing impairment predict cognitive and functional decline in older women. J Am Geriatr Soc. 2004 Dec;52(12):1996-2002. doi: 10.1111/j.1532-5415.2004.52554.x.
- Background: PubMed 27774319Gadkaree SK, Sun DQ, Li C, Lin FR, Ferrucci L, Simonsick EM, Agrawal Y. Does Sensory Function Decline Independently or Concomitantly with Age? Data from the Baltimore Longitudinal Study of Aging. J Aging Res. 2016;2016:1865038. doi: 10.1155/2016/1865038. Epub 2016 Sep 27.
- Background: PubMed 26808979Hong T, Mitchell P, Burlutsky G, Liew G, Wang JJ. Visual Impairment, Hearing Loss and Cognitive Function in an Older Population: Longitudinal Findings from the Blue Mountains Eye Study. PLoS One. 2016 Jan 25;11(1):e0147646. doi: 10.1371/journal.pone.0147646. eCollection 2016.
- Background: PubMed 30452551Brenowitz WD, Kaup AR, Lin FR, Yaffe K. Multiple Sensory Impairment Is Associated With Increased Risk of Dementia Among Black and White Older Adults. J Gerontol A Biol Sci Med Sci. 2019 May 16;74(6):890-896. doi: 10.1093/gerona/gly264.
- Background: PubMed 24587400Campbell J, Sharma A. Cross-modal re-organization in adults with early stage hearing loss. PLoS One. 2014 Feb 28;9(2):e90594. doi: 10.1371/journal.pone.0090594. eCollection 2014.
- Background: PubMed 35326458Tarawneh HY, Menegola HK, Peou A, Tarawneh H, Jayakody DMP. Central Auditory Functions of Alzheimer's Disease and Its Preclinical Stages: A Systematic Review and Meta-Analysis. Cells. 2022 Mar 16;11(6):1007. doi: 10.3390/cells11061007.
- Background: PubMed 17927921Davis A, Smith P, Ferguson M, Stephens D, Gianopoulos I. Acceptability, benefit and costs of early screening for hearing disability: a study of potential screening tests and models. Health Technol Assess. 2007 Oct;11(42):1-294. doi: 10.3310/hta11420.
- Background: PubMed 29956590Timmer BHB, Hickson L, Launer S. Do Hearing Aids Address Real-World Hearing Difficulties for Adults With Mild Hearing Impairment? Results From a Pilot Study Using Ecological Momentary Assessment. Trends Hear. 2018 Jan-Dec;22:2331216518783608. doi: 10.1177/2331216518783608.
- WORLD REPORT ON HEARINGLink provided by the sponsor.
- Methods for Analysing and Reporting EQ-5D Data \[Internet\]. Cham (CH): Springer; 2020. Chapter 1, An Introduction to EQ-5D Instruments and Their ApplicationsLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The HAHA Steering Committee and Management Group are open to requests from external researchers for data collected in this study. Applicants will be asked to submit a study protocol, including the research question, planned analysis, and data required. Committee will evaluate this plan (i.e., relevance of the research question, suitability of data, quality of proposed analyses, planned/ongoing HAHA analyses, and other matters) on a case-by-case basis and provide the data or reject the request. Shared data will encompass the data dictionary and de-identified data only. Any analysis will be conducted in collaboration with the HAHA Management Group. Access is subject to the HAHA legal framework. An access agreement will be prepared and signed by both parties.
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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. This study is not recruiting at the moment.
Aarno Dietz, prof. principal investigator
Kuopio University Hospital and University of Eastern Finland
Alina Solomon, prof. principal investigator
University of Eastern Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualised data-driven hearing rehabilitation in people with Sensorineural Hearing Loss and Cognitive Decline, run by Kuopio University Hospital at 1 site in Finland.
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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 4 Mar 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 Finland. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Finnish Matrix Sentence Test (FMST) (time frame: Change measures: 0 months, 12 months, 24 months). The study lists 2 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 NCT06495268, which also lists 34 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 4 Mar 2026.