---
title: "Data-driven hearing rehabilitation versus standard care trial: protocol for older adults with hear"
id: "bmj-open-19-proof-of-concept-randomised-controlled-trial-of-data-driven-hearing"
canonical_url: "https://medichelpline.com/clinical-feed/bmj-open-19-proof-of-concept-randomised-controlled-trial-of-data-driven-hearing"
content_type: "clinical_feed_article"
specialty: "Neurology"
source_name: "BMJ Open"
source_url: "http://bmjopen.bmj.com/cgi/content/short/16/7/e122681?rss=1"
published_at: "2026-07-21T12:12:52.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Data-driven hearing rehabilitation versus standard care trial: protocol for older adults with hear
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/bmj-open-19-proof-of-concept-randomised-controlled-trial-of-data-driven-hearing
- **Specialty:** [Neurology](https://medichelpline.com/clinical-feed/neurology.md)
- **Primary Source:** BMJ Open
- **Source URL:** [Original Journal Publication](http://bmjopen.bmj.com/cgi/content/short/16/7/e122681?rss=1)
- **Published At:** 2026-07-21T12:12:52.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- The HAHA (healthy hearing for healthy ageing) study is a proof-of-concept, single-site, two-arm parallel-group randomised controlled trial embedded in routine clinical practice at Kuopio University Hospital. It compares a structured **data-driven hearing rehabilitation** (DDHR) programme with routine standard care in older adults with mild to moderately severe sensorineural hearing loss and without cognitive impairment. - Up to 200 participants aged 65–84 years are recruited from clinical referrals and randomised 1:1. Recruitment began 1 October 2024; primary completion is anticipated by 29 February 2028. Inclusion and exclusion criteria (eg, excluding conductive or asymmetrical loss, diagnosed cognitive impairment) are defined in the protocol. - The primary outcome is change in **speech perception in noise** (SPIN) measured by two Finnish-validated tests: the Finnish matrix sentence test (FMST) and the digits-in-noise (DIN) test, reported as speech reception thresholds (SRT50). - Secondary outcomes include multiple patient-reported outcome measures (HERE, SSQ), HA usage (self-report and logged data), listening effort metrics, tinnitus handicap inventory, cognitive tests (CERAD-nb global and domain scores), Clinical Dementia Rating Sum of Boxes, quality-of-life instruments (15D, EQ-5D-5L) and depression measures (including Beck Depression Inventory). - Exploratory outcomes probe neural and structural correlates: cortical auditory evoked potentials (CAEPs) from EEG, speech-evoked sustained potentials, and structural brain MRI volumetrics, plus lifestyle and vision-related measures and other biomarkers. - DDHR is a clinician-led, structured fitting and follow-up approach using established verification (eg, real-ear measurements when indicated) and systematic objective outcome monitoring (SPIN, HA logs, PROMs) to guide rehabilitation decisions; it does not use algorithmic or AI decision-making. Standard care uses manufacturers’ fitting algorithms and performs REM only in complex cases per clinical judgement. - Randomisation uses computer-generated blocks of four with sealed envelopes; outcome assessors are masked. Complete double-masking is not feasible, and participants are not actively informed of allocation though masking may be incomplete because of protocol differences. - Assessments occur at baseline and at 12 and 24 months after the first HA fitting (which follows routine wait-times of 3–6 months). Analyses will follow CONSORT guidelines and intention-to-treat principles, excluding participants who withdraw consent. - The trial aims to evaluate feasibility and potential cognitive or neural benefits of optimised hearing rehabilitation and to identify outcome measures relevant to healthy ageing. Ethical approval was obtained (Regional Medical Research Ethics Committee of the well-being Services County of North Savo, approval no. 697/2023) and the trial is registered (NCT06495268). - Strengths include embedding in routine practice, a pragmatic usual-care control arm, sample size up to 200, and extended follow-up; limitations include potential insufficient time to capture substantial cognitive decline and incomplete masking.
## Clinical Analysis & Structured Key Points
Skip to main content Intended for healthcare professionals Log In Basket Search for this keyword Advanced search Latest content Archive For authors About Browse by collection You are here Home Archive Volume 16, Issue 7 Email alerts Article Text Article info Citation Tools Share Rapid Responses Article metrics Alerts PDF Ear, nose and throat/otolaryngology Protocol Proof-of-concept randomised controlled trial of data-driven hearing rehabilitation versus standard care in older adults with hearing loss: the healthy hearing for healthy ageing protocol http://orcid.org/0000-0003-2420-4457Laura Ihalainen1,2, Mariagnese Barbera2,3, Timo Törmäkangas4, Petteri Hyvärinen1, Tytti Willberg5, Pia Linder1,2, Alina Solomon2,3,6, Aarno Dietz1,2 Correspondence to Laura Ihalainen; laura.ihalainen@pshyvinvointialue.fi Abstract Introduction Hearing aids (HAs) can alleviate hearing loss; however, HA rehabilitation is frequently hampered by delayed diagnosis, suboptimal fitting and lack of systematic follow-up. Although the association between hearing loss and cognitive decline has been identified, evidence from randomised controlled trials remains limited. Addressing these gaps is essential for reducing hearing loss-related experiences and evaluating whether effective HA use could reduce the risk of cognitive decline. Methods and analysis The healthy hearing for healthy ageing study is a proof-of-concept, single-site, two-arm parallel-group 12-month randomised controlled trial with a 12-month extended follow-up. Up to two hundred participants with hearing loss and without cognitive decline referred for an initial HA rehabilitation are recruited and randomised 1:1 to either data-driven hearing rehabilitation or standard care. The primary outcome is the change in two speech perception in noise tests validated for the Finnish language: the Finnish matrix sentence test and the digits-in-noise test. The secondary outcomes are patient-reported outcomes (eg, Hearing in Real-Life Environment and Speech, Spatial and Quality questionnaires), quality of life (eg, 15D-questionnaire), cognitive (eg, Consortium to Establish a Registry for Alzheimer’s Disease test) and psychosocial measures. Exploratory outcomes include event-related responses, cortical auditory evoked potentials, structural brain imaging and vision-related measures. Ethics and dissemination Ethical approval has been obtained from the Regional Medical Research Ethics Committee of the well-being Services County of North Savo (approval no. 697/2023). Findings from this study will be disseminated through peer-reviewed publications, conference presentations and relevant clinical and patient communities. Trial registration number NCT06495268 https://creativecommons.org/licenses/by/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/. https://doi.org/10.1136/bmjopen-2026-122681 Request Permissions If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways. Request permissions STRENGTHS AND LIMITATIONS OF THIS STUDY Embedding the trial in routine clinical practice with recruitment through clinical referrals enhances real-world relevance and reduces selection bias. The randomised controlled design, large sample size (N up to 200) and extended duration strengthen the study in a previously underexplored area. The usual-care control arm supports real-world applicability, with variability managed through systematic tracking of key rehabilitation variables. Double-masking is implemented as far as feasible: all participants receive identical hearing aids, assessors are masked and participants are not explicitly informed of group allocation. Follow-up may be limited to capture substantial cognitive decline or incident dementia, although extended follow-up is planned. Introduction Hearing loss is a major public health concern affecting 20% of the global population (6% with moderate to complete, ie, disabling hearing loss).1 Hearing loss is among the leading causes of years lived with disability in older adults.1 Due to the ageing of the population, it is estimated that over 900 million people will have significant hearing loss by the year 2050.2 The Lancet Commission on dementia prevention, intervention and care identifies hearing loss as one of the most relevant, potentially modifiable risk factors for cognitive decline and dementia. The Commission estimated that eliminating hearing loss in mid-life might reduce the risk of dementia by 7%.3 Even though a causal relation between hearing loss and cognitive decline is yet to be established, hearing rehabilitation may be an effective intervention for reducing risk factors such as social isolation, anxiety and depression, which have been linked to hearing loss as well as cognitive decline.4 A recently published multicentre randomised trial (The Ageing and Cognitive Health Evaluation in Elders Study) demonstrated that hearing intervention reduced cognitive decline by 48% over 3 years in older adult participants with other risk factors for dementia.5 The underlying mechanisms by which hearing interventions may slow down cognitive decline remain largely unknown. Therefore, to substantiate the role of hearing interventions in reducing the risk of cognitive decline, clinical studies are needed to comprehensively explore various outcome measures and identify those that are most relevant to promote healthy ageing. Findings on the factors determining the success of hearing aid (HA) interventions vary widely, and there is no consensus on the most relevant outcome measures for evaluating these interventions.6 7 This lack of agreement contributes to the infrequent validation of hearing rehabilitation outcomes in clinical settings. Consequently, there is a surprising paucity of clinical data on real-world HA use and its benefits, which hinders evidence-based decision-making.6 Additionally, the absence of systematic follow-up may help explain the low levels of HA adoption and compliance. Currently, the success of hearing rehabilitation is most often evaluated using patient-reported outcome measures (PROMs). Despite being low cost, PROMs are rarely implemented in hearing rehabilitation processes for older adults in clinics. While PROMs provide valuable insights into a patient’s subjective experiences and perceptions, they are insufficient and unreliable for evaluating audiological outcomes, as the results do not necessarily align with objective measurements.8 Older adults, in particular, have been shown to underestimate the degree of their hearing loss in PROMs.9 Additionally, many hearing-related PROMs have not been adequately validated, further decreasing their reliability. Performance-based measures, such as speech intelligibility in noise (SPIN), can be particularly effective in capturing the everyday challenges posed by hearing loss. SPIN evaluates an individual’s ability to understand speech in noisy or reverberant environments and is currently the most appropriate measure of the real-world impact of hearing loss. Therefore, systematically measuring pre- and post-intervention SPIN could provide valuable data about the relevant factors for hearing rehabilitation. Electrophysiological measurements of auditory pathways would represent another promising approach for the objective assessment of hearing loss and HA effects. Clinical studies have demonstrated that regular HA use can modify the auditory system, often referred to as acclimatisation to HA use. Acclimatisation is a process in which HA users not only become gradually accustomed to amplification but also gradually develop better hearing performance. However, the potential extent of adaptation of a given individual’s auditory system remains largely unknown.10 11 It is also unclear whether HAs can induce beneficial plastic changes in perceptual functions relevant to SPIN. The possible neural mechanisms triggered by HA use are still unknown, and if neural changes occur, the physiological mechanisms underlying these changes are yet to be determined.12 Dual sensory impairment (DSI) refers to the presence of both hearing and vision loss, with a prevalence between 10% and 20% in older adults (> 70 years).13 Previously, hearing and vision loss have been independently linked to a higher risk of cognitive decline; however, the impact of DSI on this risk remains inconclusive.14 It has been demonstrated that the concerns in DSI are considerably greater than the effects of vision or hearing loss alone, since individuals with dual sensory differences may experience greater activity limitations and participation restrictions than those with hearing or vision loss alone.15 Currently, there are no best-practice guidelines for the rehabilitation of individuals with DSI. The healthy hearing for healthy ageing (HAHA) study is a randomised controlled trial (RCT) investigating whether considering hearing loss as a broader degenerative condition can improve both hearing and cognitive outcomes. This trial compares a data-driven hearing rehabilitation (DDHR) programme with standard care in older adults with mild to moderately severe hearing loss and without cognitive decline. DDHR is an evidence-based rehabilitation programme developed for this study in accordance with current best practices in hearing rehabilitation. Standard care corresponds to the current model of hearing rehabilitation in Finland, as described in more detail in the Methods section. The primary outcome measure is the improvement in SPIN following HA rehabilitation, serving as a key indicator for hearing function. In addition, this trial aims to address the broader neural and cognitive mechanisms, which is why we included secondary outcome measures assessing auditory processing and brain function, including structural MRI, as well as cortical auditory evoked potentials (CAEPs). These measures are intended to explore whether more effective hearing rehabilitation, reflected in improved real-world listening function, is associated with measurable neural or cognitive changes. While the DDHR programme evaluated in this trial is intended to optimise functional hearing outcomes through a more structured rehabilitation process, its implementation may require additional clinical time and resources that are not routinely available in everyday audiology practice. Consequently, an important secondary objective of this proof-of-concept study is also to evaluate the feasibility of the DDHR programme and identify strategies to support its implementation in routine clinical care. Eventually, the HAHA trial aims to establish a personalised, data-driven approach to hearing rehabilitation that could contribute to healthy ageing in older adults with hearing loss. Methods and analysis Study design HAHA is a proof-of-concept, single-site, two-arm parallel group, 12-month RCT with a 12-month extended follow-up (figure 1). Eligible participants are randomly allocated 1:1 to either the DDHR programme (active group) or the standard care (control group). In this study, ‘data-driven hearing rehabilitation’ refers to a structured, clinician-led fitting approach in which established verification procedures are used to ensure accurate amplification, combined with the systematic use of objective outcome measures (eg, SPIN performance, HA usage data and PROMs) to guide rehabilitation decisions according to predefined criteria. This approach is clinician-implemented and does not involve algorithmic or artificial intelligence-based decision-making. Standard care corresponds to the routine hearing rehabilitation programme currently provided at the Kuopio University Hospital (KUH) ENT clinic. HAs will be fitted using the manufacturers’ proprietary fitting algorithms, and real-ear measurements (REM) will be performed only in complex cases, based on the clinical judgement of the audiometrician. The main difference is that routine standard care does not typically include systematic assessment of rehabilitation outcomes, which may contribute to suboptimal outcomes and reduced adherence to HA use. To ensure a balanced distribution between the groups, randomisation is performed using a computer-generated list in blocks of four and with sealed envelopes. The list and the envelopes are prepared by a biostatistician and used by a study nurse to randomise the participants. Although double-masking is not possible, outcome assessors will be masked to the group allocation. Participants will not be actively informed of their group allocation; however, complete masking may not be feasible based on differences between the HA fitting protocols. The HAHA trial is completely embedded in clinical practice, and all trial participants will receive the same HAs as in routine care. Due to its pragmatic approach, the HAHA trial will follow the standard care wait-time (3–6 months) for the primary HA fitting visit, which marks the beginning of the intervention. Analyses will follow CONSORT guidelines16 and will include the intention-to-treat population, that is, all randomised participants, except for those who withdraw their consent (including for use of data). The Standard Protocol Items: Recommendations for Interventional Trials checklist17 18 is also included in the present protocol paper (online supplemental material S1). Supplemental material [bmjopen-2026-122681supp001.pdf] Download figure Open in new tab Download powerpoint Figure 1 Study diagram. BREM, benefits of real-ear measurements; HA, hearing aid; ISO, International Organization for Standardization; KUH, Kuopio University Hospital. Participants Up to 200 older adults (65–84 years of age) with mild to moderately severe sensorineural hearing loss1 are recruited from October 2024 onwards at the KUH among patients referred to the ENT clinic for HA rehabilitation of sensorineural hearing loss. Patients with conductive or asymmetrical hearing loss, HA contraindications, diagnosed cognitive impairment or cognitive concern under evaluation or any health condition affecting their ability to participate in the study are excluded. The eligibility criteria for the trial are presented in table 1. Patients are first screened as part of their routine hearing loss assessment appointment by an ENT specialist, and eligible patients are invited to participate in the study. A study nurse will obtain informed consent from the participants during the same appointment (online supplemental material S2). The recruitment for this study started on 1 October 2024, and the anticipated primary completion date is estimated to be 29 February 2028. Supplemental material [bmjopen-2026-122681supp002.pdf] VIEW INLINE VIEW POPUP Table 1 Eligibility criteria Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research. Patients will be recruited only as study participants. Data collection Eligible participants (table 1) are undergoing baseline assessments prior to randomisation. The same outcome assessments will be repeated at 12-month and 24-month follow-up visits after the beginning of the intervention, which is defined by the date of the first HA fitting appointment. Table 2 and online supplemental material S3 summarise the time schedule of the HAHA assessments. All outcome assessments are performed by study nurses specifically trained in the HAHA study procedures, who are masked to participants’ group allocation. Supplemental material [bmjopen-2026-122681supp003.pdf] VIEW INLINE VIEW POPUP Table 2 Schedule of enrolment, interventions and assessments of the HAHA trial Primary outcomes Change in SPIN will be assessed with two tests/outcome measures: the Finnish matrix sentence test (FMST)19 and digits-in-noise (DIN) test.20 21 FMST is a functional audiological test validated for the Finnish language.19 In the test, participants listen to 5-word sentences chosen from a standardised and optimised word matrix, which allows for 105 different sentences of equal intelligibility. Each test list contains 20 randomly chosen sentences. The sentences are presented to the participants under stationary background noise (65 dB SPL) generated from the speech material of the FMST. The test is presented in the S0N0 condition, which means that the signal and background noise are presented through one loudspeaker at a 0° azimuth. Three test lists will be presented to the participants. The participants repeat all the words they can identify, and they are allowed also to guess words that they could not hear clearly. The result of the FMST is the signal-to-noise ratio (SNR) at which the participant correctly identifies 50% of the presented word items; this is called the speech reception threshold (SRT50). DIN is a functional hearing test20 validated for the Finnish language.21 The word material of the test consists of digit triplets presented under stationary background noise (65 dB SPL). The result of DIN is the SNR at which the participant correctly identifies 50% of the presented triplets (SRT50). The DIN will be performed as a closed-set test, which means that the participant types their responses via a touch screen. Participants will be tested during the baseline visit without HAs and during the following visits (12 and 24 months) with and without HAs in both ears simultaneously. Secondary outcomes Changes in the following secondary endpoints will be included: Hearing in Real-Life Environment (HERE)22 and Speech, Spatial and Qualities of Hearing Scale (SSQ)23; HA usage, self-report and HAs log-data; listening effort questionnaire24; response time of the DIN test and tinnitus handicap inventory (THI)25; Consortium to Establish a Registry for Alzheimer’s Disease -test’s (CERAD-nb) global and domain scores26; Clinical Dementia Rating Sum of Boxes27; health-related quality of life (15D and EQ5-D-5L questionnaires28 29); self-reported depression symptoms and Beck Depression Inventory30 (table 2, online supplemental materials S3 and S4). Supplemental material [bmjopen-2026-122681supp004.pdf] Exploratory outcomes A range of exploratory analyses will investigate potential intervention effects on active lifestyle (change in lifestyle factors related to cognitive decline, eg, physical, cognitive and social activities) as well as accessible and non-invasive biomarkers as possible predictors of hearing rehabilitation benefits. These biomarkers include electroencephalogram (EEG)-derived CAEPs, in which the analysis focuses on the amplitude, latency and duration of the sustained potential of the speech-evoked response and brain structural MRIs probing the effects of hearing impairment and rehabilitation on volumetric measures. The full list of exploratory outcome measures is presented in online supplemental material S3. Other data collected Other relevant data will be collected, including demographics, medical history, anthropometrics, subjective memory questionnaire,31 Basic Nordic Sleeping Questionnaire32 and other lifestyle-related risk factors for cognitive decline (eg, diet, smoking and alcohol consumption). Audiograms will be obtained through pure-tone audiometry using an Aurical Aud audiometer (Natus Medical Incorporated, Middleton, WI, US) with TDH39 audiometric headphones (TTM Technologies Inc., St. Louis, MO, US) in a soundproof booth, following international standards (ISO 8253–1:2010). Air conduction (AC: 250–8000 Hz) and bone c
## Related Clinical Research

- [Carbon monoxide exposure may explain lower Parkinson's risk linked to smoking](https://medichelpline.com/clinical-feed/medical-news-today-0-why-smokers-may-have-a-lower-parkinson-s-risk-it-s-not-the-nicotine.md)
- [2026 Stroke Rehabilitation Guideline: Start Early and Address Physical, Cognitive, and Mental Heal](https://medichelpline.com/clinical-feed/medical-news-today-0-stroke-rehab-guidelines-emphasize-early-support-for-physical-cognitive-and.md)
- [Genetic Ancestry Versus Self-Reported Race Alters Neuropsychiatric Symptom Estimates in Alzheimer'](https://medichelpline.com/clinical-feed/medrxiv-21-discordance-between-genetic-ancestry-and-self-reported-race-impacts-inference.md)
- [Neurocognitive and Psychological Symptoms in Post-COVID-19 (PASC24) — Access Blocked; Protocol Det](https://medichelpline.com/clinical-feed/bmj-open-8-neurocognitive-and-psychological-symptoms-in-post-covid-19-patients-pasc24.md)
- [Rising Demand for Plastic Surgery Among Young Men Fueled by Influencers and Looksmaxxing](https://medichelpline.com/clinical-feed/stat-news-1-opinion-more-young-men-are-coming-to-me-for-plastic-surgery-the-way-i-think.md)

## Navigation
- [← Back to Neurology Feed](https://medichelpline.com/clinical-feed/neurology.md)
- [← All Clinical Specialties](https://medichelpline.com/clinical-feed.md)
## Medical & Regulatory Disclaimer

> [!CAUTION]
> MedicHelpline content is structured for research, educational, and professional discovery purposes. It does not constitute individual medical advice, clinical diagnosis, or treatment recommendations.
> Always verify dosing, contraindications, and regulatory alerts against official product labeling and primary regulatory sources before clinical decision-making.