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Original Research

Frontiers in Audiology and Otology ·

Volume 4 - 2026 | https://doi.org/10.3389/fauot.2026.1798374

Impact of bone conduction hearing devices on health-related quality of life in chronic otitis media-related hearing loss: a systematic review and meta-analysis

  • Xing Wang1,2,3*corresponding author
  • Wangwei Li4
  • Junmei Miao Jonasson1,2*corresponding author
  1. 1Department of Public Health, Goteborgs Universitet Sahlgrenska Akademin, Gothenburg, Sweden
  2. 2University of Gothenburg, Gothenburg, Sweden
  3. 3Cochlear Limited, Mölnlycke, Sweden
  4. 4Otorhinolaryngology Department, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing, China
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Abstract

To evaluate the effectiveness of bone conduction hearing device (BCHD) in improving health-related quality of life (HRQoL) among the adults chronic otitis media (COM) patients with hearing loss. A systematic literature search was conducted in PubMed, Scopus, Embase and Cochrane Library for studies published between 1 Feb, 2015 to 15 February, 2025 that reported HRQoL outcomes in adult COM patients using BCHDs. Study quality was assessed using the Newcastle-Ottawa Scale, and, and results were synthesized with a random-effect model. Nine non-randomized studies (n = 107) were included. BCHD significantly improved HRQoL (SMD = 35.50; 95% CI = 20.37–50.62, p < 0.001) with consistent audiological gains (pure tone audiometry improvements of 38–52 dB). Studies were rated as moderate to high quality. BCHDs provide substantial positive effects on HRQoL for adults with COM-related hearing loss, representing an important public health intervention. Future research should employ larger controlled studies to strengthen the evidence base for policy and practice.

Keywords

Introduction

Chronic otitis media (COM), particularly chronic suppurative otitis media (CSOM) represents a substantial global public health problem (Monasta et al., 2012; Bhutta et al., 2024), with estimates from the World Health Organization (WHO), an estimated 65 to 330 million people worldwide suffer from COM, of whom approximately 60% experience significant hearing impairment (World Health Organization, 2004; Haile et al., 2021). With a persistent inflammation of the middle ear, COM results in conductive hearing loss, which is recognized as a disabling condition with numerous secondary complications (Alkhaldi et al., 2025; Backous et al., 2022).

The impact of COM on patients' health-related quality of life (HRQoL) is profound. Chronic inflammation and hearing impairment reduce patients' ability to participate in daily life, thereby diminishing overall well-being (Pérez-Herrera et al., 2020). Studies demonstrated that patients with chronic otitis media experience a long-standing and substantial burden of disease, both clinically and socioeconomically (Pérez-Herrera et al., 2020).

Surgical intervention is often required to manage COM and prevent potentially life-threatening complications such as facial nerve palsy, labyrinthitis, mastoiditis, meningitis, and intracranial abscesses. Procedures like tympanoplasty or ossicular chain reconstruction are commonly performed to restore hearing (Indorewala et al., 2015). However, these approaches may not be effective for all patients, particularly those with malformations of the middle or external ear or dysfunction of the eustachian tube (Mudhol et al., 2013). Bone conduction hearing devices offer an advantage in chronic otitis media by transmitting sound directly through the skull to the cochlea, thereby bypassing the external auditory canal and tympanic membrane. This mechanism allows them to remain effective despite persistent ear drainage (Snik et al., 2001).

Bone conduction hearing devices (BCHD) have emerged as a critical technological intervention for this patient population. BCHD have demonstrated potential in improving both audiological outcomes and HRQoL (Marszał et al., 2021). Bone conduction hearing solutions have become a vital tool in audiology for individuals suffering from specific types of hearing loss, particularly those with conductive hearing loss, mixed hearing loss, or single-sided deafness (Backous et al., 2022). These hearing solutions bypass damaged parts of the ear—such as the eardrum or ossicles—by transmitting sound vibrations directly to the inner ear via the bones of the skull. Since the first implantation described by Tjellström and Granström in 1977, skin-penetrating implants have been utilized for the retention of Bone Anchored Hearing Aids (BAHA), marking a significant advancement in the treatment of conductive and mixed hearing loss. The findings demonstrated a high rate of implant stability, with 90% remaining securely in place. Overall, the percutaneous coupling of the device in the mastoid bone proved to be a safe, reliable, and minimally problematic approach for long-term hearing rehabilitation (Tjellström and Granström, 1994). Evidence suggests that BCHD offer significant benefits for patients with persistent otorrhea, otitis externa, or those unable to use conventional air conduction hearing aids (Snik et al., 2001). Additionally, they have shown promising results in populations with unilateral conductive hearing loss or single-sided deafness (SSD), enhancing speech perception and social participation (Ellsperman et al., 2021). Despite their proven clinical efficacyPercutaneous hearing solutions compromise the integrity of the skin barrier, necessitate lifelong daily hygiene, and are associated with a risk of local skin complications. To address these challenges, novel bone conduction implant (BCI) systems have been developed. Unlike percutaneous systems, transcutaneous BCIs transmit sound signals through intact skin to an implanted transducer, thereby minimizing skin complications and improving cosmetic outcomes (Kim et al., 2023). Despite their increasing use, a comprehensive, quantitative synthesis of their impact on the HRQoL of adult COM patients is lacking. Evaluating the impact of BCHDs on HRQoL requires validated patient-reported outcome measures (PROMs) that capture both hearing-specific and generic health domains. Three instruments are predominantly used in bone conduction hearing device research. The Abbreviated Profile of Hearing Aid Benefit (APHAB) is a 24-item inventory assessing communication difficulty across four subscales—ease of communication, reverberation, background noise, and aversiveness—yielding both global and domain-specific scores (Cox and Alexander, 1995). The Speech, Spatial and Qualities of Hearing Scale (SSQ) is a 49-item questionnaire evaluating hearing disability across three domains: speech recognition, spatial hearing, and hearing qualities such as clarity and naturalness; it is particularly sensitive to binaural hearing function and directional hearing ability (Gatehouse and Noble, 2004). The Health Utilities Index Mark 3 (HUI-3) is a generic health status instrument encompassing eight health attributes, including a dedicated hearing domain, and yields a utility score ranging from 0 (death) to 1.0 (perfect health); it is considered more sensitive to hearing interventions than other generic instruments such as the EQ-5D and supports the calculation of quality-adjusted life years (QALYs) for health economic evaluations (Feeny et al., 2002). These instruments were selected for this review on the basis that they represent the most frequently utilized PROMs in BCHD outcome research.

This study aims to address this gap by conducting a systematic review and meta-analysis of existing literature to assess the effect of BCHDs on health-related quality of life (HRQoL), as measured by PROMs. By quantifying these outcomes, the study seeks to provide evidence for clinicians, policymakers, and patients regarding the effectiveness of BCHD.

Methods

Study design and registration

This systematic review and meta-analysis followed the PRISMA 2020 guidelines (Page et al., 2021). The protocol was registered in PROSPERO (CRD420251004459).

Data sources

Two authors (1 and 2) conducted a systematic search in four major biomedical and health science databases: PubMed, Embase (Elsevier), Scopus (Elsevier), and the Cochrane Library (Wiley). The date range for included studies was set from 1 February 2015 to 15 February, 2025, with disagreements resolved by Author 3.

Search strategy and Keywords: the search terms combined controlled vocabulary (MeSH) and free-text keywords:

  • Population: “chronic otitis media” OR “CSOM” OR “otitis media with effusion” OR “glue ear”
  • Intervention: “bone conduction” OR “bone-anchored hearing device” OR “bone conduction hearing implant”
  • Outcome: “quality of life” OR “HRQoL” OR “health-related quality of life”

Final search yielded 675 records (PubMed 172, Embase 207, Cochrane 78, Scopus 218) (See Appendix A).

Eligibility criteria

Inclusion: (1) Population: Adult patients (≥18 years old) diagnosed with Chronic Otitis Media (COM) with hearing loss;(2) Intervention: Use of any surgically implanted or non-surgically applied BCHD;(3) Reported quantitative data on health-related quality of life (HRQoL) outcomes using validated patient-reported outcome measures (PROMs);(4) Randomize or non-randomized studies (prospective cohort, observational, cross-sectional, or retrospective studies).

Exclusion: (1) Pediatric populations;(2) Interventions other than BCHDs;(3) Descriptive-only analyses without validated HRQoL data. (4) Reviews, case reports, and editorials and conference abstract without full text; (5) Non-English publications; (6) Studies outside date range: (7) Studies without ethics committee approval or informed consent documentation.

Study selection and data extraction

This study is a systematic review and meta-analysis following PRISMA guidelines (Page et al., 2021). Rayyan was used to identify and remove duplicate records during the initial screening phase of the systematic review (Ouzzani et al., 2016). Two authors independently screened titles/abstracts (568 records) and full texts (83 articles), with disagreements resolved by consensus (Author 3). Data extraction (in duplicate) included: study characteristics (author, year, country, design), participant demographics (n, age, COM type), intervention details (BCHD type, implantation method), HRQoL measures (PROM type, pre/post scores, SMD/effect sizes), adverse events, and quality indicators. Authors were contacted for missing data.

Quality assessment

Newcastle-Ottawa Scale (NOS) was applied by two independent raters (author 1 and 2) for non-randomized studies, awarding 0–9 stars (selection 4 stars, comparability 2 stars, outcome 3 stars). Quality categories: high (7–9), moderate (4–6), low (<4) (Wells and Shea, 2021). Risk of bias in non-randomized interventions (ROBINS-I) was assessed independently (Sterne et al., 2016).

Outcome measures

Primary outcome: health-related quality of life (HRQoL)measured via validated patient-reported outcome measures (PROMs) including APHAB, HUI-3, and Speech, Spatial and Qualities of Hearing Scale (SSQ) (See Appendix C).

APHAB (Abbreviated Profile of Hearing Aid Benefit) is a validated patient-reported outcome measure assessing hearing aid effectiveness across four key domains (Cox and Alexander, 1995).

Health Utilities Index Mark 3 (HUI-3) is a comprehensive, preference-based measure that includes a specific domain for hearing ability, enabling the calculation of utility scores for economic evaluations and quality-adjusted life years (QALYs) (Feeny et al., 2002).

Spatial and Qualities of Hearing Scale (SSQ), is designed to assess subjective hearing ability across three distinct domains: speech hearing, spatial hearing, and qualities of hearing (e.g., clarity and naturalness).

Statistical analysis

All statistical analyses were performed using StataNow/SE 19.5 (StataCorp, Revision 08 Apr 2025)-Given the use different PROMs across studies, we calculated the standardized mean difference (SMD) for search study to estimate the effect size. A random-effects model, specifically the DerSimonian-Laird method, was employed to pool standardized mean differences (SMDs) with 95% confidence intervals (CIs) to account for anticipated heterogeneity (Higgins et al., 2024).

Heterogeneity was assessed using Cochran's Q chi-square test and the I2 statistic (Higgins et al., 2024). The Q test was evaluated whether observed differences in effect sizes are due to chance (p < 0.10 indicating significant heterogeneity), while I2 quantified the proportion of variability attributed to between-study differences (I2 > 50% indicating moderate to high heterogeneity).

To examine heterogeneity in health-related quality of life (HRQoL) outcomes among patients with chronic otitis media (COM), subgroup analyses were conducted based on the type of patient-reported outcome measure (PROM) used. The robustness of pooled effect sizes were tested by sensitivity analyzes, excluding studies with high risk of bias, assessing the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) for observational studies (Sterne et al., 2016). Funnel plots provided visual assessment of publication bias; Egger's regression test was planned (p < 0.05 threshold) but underpowered with n = 9 studies.

Ethical considerations

Per PRISMA and Cochrane guidelines, systematic reviews synthesizing published data typically bypass de novo ethics approval. Nonetheless, to uphold patient safeguards and data quality, only studies with documented ethics committee/IRB clearance and explicit informed consent procedures were eligible (Higgins et al., 2024). All included studies complied with the Declaration of Helsinki and received ethics committee approval.

Results

The literature research identified 675 records were identified across PubMed, Embase, Scopus, and Cochrane Library (01 February 2015 to 15 February, 2025). After screening 568 titles and abstracts,83 full-text articles were assessed for eligibility. Ultimately, 9 non-randomized studies met the inclusion criteria and were included in meta-analysis. A PRISMA screening process is provided in Figure 1.

PRISMAflow diagram illustrating the study selection process. PRISMA, Preferred Reporting Items for Systematic Review and Meta-analysis.
Figure 1. PRISMAflow diagram illustrating the study selection process. PRISMA, Preferred Reporting Items for Systematic Review and Meta-analysis.

The nine included studies, published between 2019 and 2024, represented a total of 107 adult patients with COM from six different countries. The studies were primarily prospective cohort designs (n = 7), with follow-up periods ranging from one to 12 months. The interventions included various BCHD systems (e.g., Ponto, Baha, Osia, Bonebridge) and HRQoL was assessed using several validated PROMs, The methodological quality of the included studies was generally moderate to high, with Newcastle-Ottawa Scale (NOS) scores ranging from 6 to 9 stars.

To assess the methodological quality and risk of bias of the included observational studies, the Newcastle-Ottawa Scale (NOS) was employed (Appendix B) (Wells and Shea, 2021). Each study can be awarded up to nine stars, reflecting higher methodological rigor. The quality assessment was conducted independently by A1 and A3 in duplicate to ensure consistency and transparency. Discrepancies were resolved through discussion. The outcomes of this appraisal inform the strength and reliability of the synthesized evidence were summarized in Table 1 below.

Table 1. Newcastle -Ottawa Scale (NOS) quality assessment for meta-analysis studies.

ReferencesSelection (4)Comparability (2)Outcome (3)Total score (9)Quality level
Pérez-Carbonell et al. (2019)⋆⋆⋆⋆⋆⋆6Moderate
Gawecki et al. (2022)⋆⋆⋆⋆⋆⋆6Moderate
Marszał et al. (2021)⋆⋆⋆⋆⋆⋆⋆⋆8High
Lewis and Gergely (2022)⋆⋆⋆⋆⋆⋆⋆7High
Kim et al. (2023)⋆⋆⋆⋆⋆⋆⋆⋆⋆9High
Garcier et al. (2021)⋆⋆⋆⋆⋆⋆⋆7High
Nevoux et al. (2023)⋆⋆⋆⋆⋆⋆⋆⋆⋆9High
Gawecki et al. (2025)⋆⋆⋆⋆⋆⋆⋆⋆8High
Collins et al. (2024)⋆⋆⋆⋆⋆⋆⋆⋆⋆9High

Quality categories: High (7–9 stars), Moderate (4–6 stars), Low (<4 stars).

Recommendations: Use high-quality studies (scores 7–9) for primary analysis. Conduct sensitivity analyses excluding moderate-quality studies to assess robustness.

Study characteristics

The included studies reported HRQoL outcomes using various PROMs, with APHAB (7 studies), SSQ (3 studies), and HUI-3 (2 studies) being the most common. The majority of studies (n = 7) utilized a pre-post design to assess the changes in HRQoL before and after bone conduction hearing devices placement, while two studies adopted mixed methodologies: one combined prospective data collection for the Osia group with retrospective data for controls, evaluating outcomes at 1, 3, and 6 months post-implantation; the other incorporated both retrospective and prospective elements to examine HRQoL (Marszał et al., 2021; Kim et al., 2023; Lewis and Gergely, 2022; Collins et al., 2024; Gawecki et al., 2022, 2025; Nevoux et al., 2023; Pérez-Carbonell et al., 2019). Audiological outcomes, such as functional hearing improvement [(measured via pure-tone average (PTA4)] and speech recognition, were reported in 9 studies, showing significant gains (mean PTA4 improvement: 25–41 dB HL). Adverse events, including skin irritation (5–10% of cases) and device discomfort (3–7%), were reported in six studies, with high patient satisfaction (80–95%) noted across aesthetic and usability domains. Summary of included studies showing aims, methodological characteristics, participant details and key findings in Table 2:

Table 2. Summary of included studies.

ReferencesCountryAimDesign and PROMsParticipantsInterventionKey findings
Pérez-Carbonell et al. (2019)SpainTo assess self-reported benefit from BCHD in COM patientspre-post; GBI, APHABN = 6; adults with COMBone conduction implant (unspecified type)High self-reported QoL benefit (GBI ~75); APHAB scores: pre-implantation global score 81%, post-implantation 14%.
Gawecki et al. (2022)PolandTo evaluate functional hearing benefits post-BCHDPre-post; APHABN = 5; adults with CHL/MHL from COMBaha Attract systemMean improvement ~49% APHAB points; notable hearing function gains
Marszał et al. (2021)PolandTo compare performance of BCHDPre-post; APHABN = 3; adults with COMOsia system (active transcutaneous implant)High effect size (~67%); very small sample—results exploratory
Garcier et al. (2021)UKTo assess hearing and satisfaction outcomes with BCHDPre-post; APHABN = 13; adults with CHL from COMBaha or BonebridgeAPHAB global score improved by 45 ± 7.0% (COM). Significant improvements in speech/noise domains
Lewis and Gergely (2022)*Columbia, PolandTo examine HRQoL gains from BCHDPre-post; HUI-3, SSQN = 10 (HUI-3); N = 6 (SSQ), adults with COM or cholesteatomaBaha Connect (percutaneous) and Attract (transcutaneous)Clinically relevant improvements in HUI3 hearing and pain attributes: Improved from 0.546 (pre-implant) to 0.691 (12 months post-implant).; SSQ improved, especially in spatial domain: Improved from 4.70 (pre-implant) to 6.35 (post-implant).
Kim et al. (2023)South KoreaTo evaluate surgical and QoL outcomes in COMMixed Pre-post for Osia; APHAB, HUI-3N = 9; adults post-tympanoplasty/mastoidectomyOsiaImproved hearing function and utility scores; shows synergy with surgery
Nevoux et al. (2023)FranceTo assess auditory benefits of Osia System, Baha Attract in quiet/noisy conditionsProspective; APHAB, SSQN = 6; adults with MHL (post-COM surgery or aplasia)Baha Attract and Osia systemImproved speech recognition (95% to 100%) and SNR with Osia; SSQ used but specific scores not reported; ~10 dB PTA4 gain
Gawecki et al. (2025)PolandTo reassess BCHD outcomes in a new COM groupPre-post; APHABN = 14; adults with COMOsia, Baha Attract and BonebridgeConsistent auditory benefit (mean APHAB ~31%); Significant improvements in speech understanding in noise and overall communication.
Collins et al. (2024)UKTo evaluate long-term satisfaction with BCHDPre-post; GHSIN = 41; adults with COMPantoGHSI: Median total +67.1, general well-being +96.3, physical +50, social −50 (less support needed).

Lewis et al.*: author indicates a total of 38 patients with COM or cholesteatoma (20 COM + 18 cholesteatoma), but only 10 had complete HUI3 data. Thus, the N = 10 refers specifically to the HUI3 sample, as SSQ data were limited to 6 patients.

Primary results

The primary meta-analysis demonstrated a large and statistically significant improvement in HRQoL following BCHD intervention. The pooled standardized mean difference (SMD) was 35.50 (95% CI: 20.37–50.62; p < 0.001), as shown in the forest plot in Figure 2.

Forest plot showing pooled standardized mean difference (SMD) across 9 included studies assessing HRQoL improvement following BCHD intervention in adults with chronic otitis media-related hearing loss. Random-effects REML model.
Figure 2. Forest plot showing pooled standardized mean difference (SMD) across 9 included studies assessing HRQoL improvement following BCHD intervention in adults with chronic otitis media-related hearing loss. Random-effects REML model.

The forest plot from meta-analysis demonstrates a pooled effect size of bone conduction hearing devices on HRQoL in adults' patients with chronic otitis media related hearing loss across 9 included studies. The effect sizes are substantially positive, with the summary line located far to the right of the no-effect line (vertical dot line at 0), indicating a beneficial impact of BCHDs. The 95% confidence intervals (CIs) for most studies did not cross zero, indicating statistically significant improvements in HRQoL or audiological measures. The summary diamond represents a pooled effect size of 35.50 (95% CI: 20.37–50.62), positioned substantially to the right of the no-effect line, confirming a strong and statistically significant overall beneficial effect (Z = 4.60, p < 0.001). This corresponds to moderate-to-large improvements in HRQoL (e.g., Abbreviated Profile of Hearing Aid Benefit [APHAB] global score reductions of 32–49%) or audiological gains, supporting BCHIs as an effective intervention. However, substantial heterogeneity is evident (τ2 = 503.17, I2 = 98.69%, H2 = 76.57, Q(8) = 927.16, p < 0.001), indicating that variability in effect sizes is not due to chance alone.

Subgroup analysis

High heterogeneity across studies prompted subgroup analyses by PROM type, device type, and clinical context to explore potential effect modifiers. These analyses provided insight into how different outcome measures impacted the observed benefits of BCHD. For example, APHAB targets hearing-specific benefits, while HUI-3 measures general health utility, potentially less sensitive to auditory changes. These distinctions highlight the role of different instruments/questionnaires in influencing study findings and how to justify stratified analyses to reduce methodological variability.

PROM-specified findings

APHAB (Abbreviated Profile of Hearing Aid Benefit)

Across six studies, the pooled effect size was 41.35 (95% CI: 26.15–56.54), with heterogeneity (τ2 = 201.5, I2 = 62.19%, H2 = 2.64.57, Q(5) = 12.63, p < 0.001), reflecting perceived benefit. Individual study estimates ranged widely from 18.30 to 67.10—highlighting variability in study populations, devices, and settings. The APHAB captures patient-perceived difficulty in common listening environments (e.g., background noise, reverberation), making it highly responsive to hearing-specific functional improvements. These results support the effectiveness of BCHD in improving daily communication and listening effort, see Figure 3.

Forest plot for APHAB.
Figure 3. Forest plot for APHAB.

HUI-3 (Health Utilities Index Mark 3)

Lewis et al. using the HUI-3 reported a lower effect size of 0.69 (95% CI: 0.52–0.86). As a generic utility-based instrument, the HUI-3 provides a standardized health economic perspective but is less sensitive to hearing-specific changes. While the utility gain appears modest, it is still considered clinically meaningful, particularly in public health and cost-effectiveness contexts (Lewis and Gergely, 2022).

SSQ (Speech, Spatial and Qualities of Hearing Scale)

Three studies evaluated SSQ (Speech, Spatial, and Qualities of Hearing Scale) outcomes in chronic otitis media (COM) post-BCDH implantation. Lewis and Gergely (2022) presented descriptive improvements across all three SSQ domains.

Kim et al. (2023) demonstrated significant SSQ improvement with Osia, plus correlation between 2 kHz audiometric gain the speech/spatial subdomain enhancement for patients received the Osia system after tympanoplasty or mastoidectomy. SSQ scores improved significantly following implantation, and a strong correlation was observed between audiometric gain at 2 kHz and improvements in the speech and spatial subdomains of the SSQ. This relationship underscores the instrument's sensitivity to functional change and reinforces the importance of evaluating both clinical and patient-reported outcomes when assessing intervention success. The authors also noted positive outcomes in individuals with poorer baseline bone conduction thresholds, suggesting that newer active transcutaneous technologies, particularly piezoelectric systems like the Osia, provide a significantly wider dynamic range and higher maximum power output (MPO) compared to older passive or electromagnetic devices (Kim et al., 2023). This technological advancement allows for the rehabilitation of patients with bone conduction (BC) thresholds as poor as 55–61.3 dB HL, whereas first-generation devices were typically limited to thresholds of 35–40 dB (Nevoux et al., 2023).

The third study, conducted by Nevoux et al. (2023), followed four individuals longitudinally, yielding twelve observations across multiple time points. Improvements were noted consistently in all SSQ subdomains, although effect sizes varied. Despite the small cohort, the repeated-measures design provided meaningful within-subject data on the progression of hearing-related quality of life over time (Nevoux et al., 2023).

Assessment of risk of bias and quality of evidence

The assessment of bias using the Newcastle-Ottawa Scale (NOS) indicated that the included studies were of moderate to high quality (Wells and Shea, 2021). A sensitivity analysis using the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool confirmed a moderate risk of bias, primarily attributable to the non-randomized nature of the studies and potential confounding factors (Sterne et al., 2016). A funnel plot was generated to assess publication bias, which appeared to be symmetrical.

Confounding: Studies like Marszał et al. (2021) lacked control groups, increasing confounding risk due to unadjusted factors (e.g., hearing loss etiology), consistent with NOS comparability limitations.

Publication bias

A funnel plot was constructed to assess potential publication bias among the included studies (Figures 3, 4). Each point represents an individual study's standardized mean difference (effect size) plotted against its standard error. The vertical red line indicates the pooled effect estimate, while the gray lines represent the pseudo 95% confidence limits. Visual inspection of the funnel plot shows some degree of asymmetry, with smaller studies (those with larger standard errors) tending to report larger effect sizes. This pattern may reflect potential small-study effects or publication bias, where studies with non-significant or smaller improvements are less likely to be published.

Funnel plot of studies assessing HRQoL improvement following BCHD intervention.
Figure 4. Funnel plot of studies assessing HRQoL improvement following BCHD intervention.

Discussion

To our knowledge, this is the first meta-analysis to quantify the impact of bone conduction hearing devices (BCHDs) on the health-related quality of life (HRQoL) of adults with chronic otitis media. Across nine non-randomized cohort studies (n = 107), our findings indicate that BCHDs are associated with consistent improvements in HRQoL for adults with COM-related hearing loss. The pooled standardized mean difference (SMD) of 35.50 (95% CI: 20.37 to 50.62) across nine cohort studies indicates substantial benefits in communication, social engagement, and emotional well-being along with auditory improvement. Clinically meaningful improvements, such as APHAB score reductions of more than 30 percent points and HUI-3 utility gains exceeding 0.10, underscore BCHD's effectiveness in reducing hearing-related disability (Lewis and Gergely, 2022). The SSQ findings further highlight improvements in spatial hearing as a consistent theme across included studies, capturing patient-centered dimensions of hearing ability that standard audiometric measures alone do not reflect.

For different device types, percutaneous bone conduction devices are associated with higher rates of skin complications, including local infection, skin breakdown, and need for revision surgery, which reported in 5%−42% (Gawecki et al., 2022). These systems require more frequent outpatient visits and surgical interventions for skin management (Marszał et al., 2021) (Gawecki et al., 2025).

Comparison with previous research

BCHD demonstrated a mean utility gain of 0.32 (95% CI: 0.25–0.39), whereas traditional tympanoplasty yielded a utility gain of only 0.084 (Lewis and Gergely, 2022). Kim et al. found that BCHD significantly improved HRQoL in patients with conductive or mixed hearing loss (CHL/MHL) who had undergone tympanomastoidectomy with unsatisfactory auditory outcomes, underscoring BCHD's value for complex COM cases (Kim et al., 2023).

Marszał et al. (2021) demonstrated that active transcutaneous systems, such as the Osia with its optimized transducer positioning, improve sound transmission and patient comfort compared to traditional percutaneous devices. The Osia system is highlighted for its advanced piezoelectric technology, offering greater maximum power output (MPO) at higher frequencies and fewer MRI limitations compared to electromagnetic transducer (Marszał et al., 2021). Our findings quantify the effect of BCHD, aligning with Pérez-Carbonell et al. (2019) Glasgow Benefit Inventory (GBI) results, which showed a mean general benefit score of +34, reflecting reduced social isolation and enhanced psychosocial well-being.

Strengths

A distinctive strength of this review lies in its integration of multiple patient-reported outcome measures (PROMs) across different follow-up time points, enabling a nuanced assessment of both short-term and long-term quality-of-life improvements in COM patients. Unlike previous reviews, this study quantitatively synthesizes effect sizes using standardized mean differences, allowing direct comparison across heterogeneous PROMs. Furthermore, the review applies a rigorous risk-of-bias evaluation tailored to both randomized and non-randomized studies, ensuring that the conclusions are supported by methodologically robust evidence. To ensure the robustness of the findings, the quality of non-randomized studies was assessed using the Newcastle-Ottawa Scale (NOS), with all the studies rated as moderate quality (6–9 out of 9), and a sensitivity analysis using the ROBINS-I tool. Sensitivity analysis further tested the impact of methodological variations.

Limitations

Included studies varied in design, baseline hearing loss, and outcome measures, contributing to substantial heterogeneity. Observational cohort designs without randomized controlled trials (RCTs) limit causal inference and increase selection and reporting bias. Standardized mean difference harmonization may obscure clinically meaningful differences between instruments. Although the forest plot indicates consistently positive effects, high heterogeneity warrants cautious interpretation. Insufficient data prevented comprehensive subgroup analyses. The review addressed neither device acquisition barriers nor health system factors influencing BCHD uptake in low-resource settings. Highly selected patient populations excluding complex comorbidities or socioeconomic barriers may limit generalizability to broader clinical practice.

Methodological limitations

The included studies varied in design, baseline of hearing loss, outcome measures, contributing to substantial heterogeneity. Many studies were observational cohort designs, and no randomized controlled trials (RCTs) included, limiting the ability to infer causality and increasing susceptibility to selection and reporting bias.

Standardized mean difference (SMD) was used to harmonize outcomes across different patient-reported outcome measures (PROMs), but this approach may obscure clinically meaningful differences between instruments and populations.

This review included only studies published in English, based on evidence that non-English articles comprise a small proportion of relevant literature (~9.7% in PubMed). Based on the information, we conclude that the outcomes and conclusions of this systematic literature searches are not affected by the applied English language restriction. Nonetheless, this decision may have inadvertently excluded studies from low- and middle-income countries (LMICs), where COM is more prevalent and where public health implications of hearing loss are most acute. The existing evidence base is largely derived from high-income settings, which limits generalizability to LMIC populations.

Future research

Several important research priorities emerge from this review. First, the evidence would be strengthened by randomized controlled trial and well-designed prospective cohort studies.

Second, standardization of patient-reported outcome measures, like APHAB, SSQ, and HUI-3 would reduce heterogeneity and improve evidence synthesis. Third, longer follow-up periods are needed to determine whether the HRQoL gains observed in the short term are sustained over time and to capture the full adverse event profile. Fourth, as all included studies were conducted in high-income countries, limiting generalizability to low- and middle-income settings where the burden of COM is often highest (Monasta et al., 2012). More HRQoL studies, especially in LMICs, are essential to assess BCHD's impact in high-burden regions.

Public health and equity Implications

COM imposes a significant yet under-recognized burden on public health systems, particularly in low- and middle-income countries (LMICs) where 85% of global COM burden resides (World Health Organization, 2004). BCHDs provide cost-effective long-term rehabilitation when considered alongside: (1) reduced need for repeated ear surgeries; (2) lower risk of complications (mastoiditis, meningitis); (3) improved work productivity and social participation. Health economic modeling and comparative effectiveness research in LMIC settings are urgently needed to inform equitable access policies (Tordrup et al., 2022; World Health Organization, 2017; Van Hoof et al., 2020). Access to hearing intervention in LMICs remains highly limited with only about 10% of population in need receiving care, largely due to high BCHD costs, limited surgical capacity and inadequate health infrastructure (World Health Organization, 2017). These barriers disproportionately affect rural, low income and older population and contribute to low screening update and reduce access to interventions (Coombs et al., 2022).

Research and advocacy needs

Limited cost-effectiveness data for BCHD in LMICs, particularly for marginalized groups, hinders equitable implementation (World Health Organization, 2017; Guo et al., 2024). Future studies should assess economic impacts across socioeconomic, gender, and age groups, building on this meta-analysis's clinical findings. Pilot programs combining screening with subsidized BCHD in LMICs could inform scalable, equity-focused models. Advocacy to prioritize hearing health, engaging governments and communities, can reduce stigma and improve uptake, especially among women and elderly populations.

Conclusion

This systematic review and meta-analysis suggest that bone conduction hearing devices (BCHD) markedly enhance health-related quality of life (HRQoL) for adults with chronic otitis media (COM)-related hearing loss, yielding a large and statistically significant pooled effect size of 35.50 (95% CI: 20.37 to 50.62). Analyzing nine cohort studies, we found the BCHD significant improvements in communication, social engagement, and emotional well-being. Clinically meaningful changes, such as APHAB score reductions of 30 percent points or more and HUI-3 utility gains exceeding 0.10. These findings support the clinical utility of BCHDs as a rehabilitation option for adults with COM in whom conventional surgical or air-conduction approaches have been unsuccessful or are contraindicated. However, the conclusions of this review should be interpreted with appropriate caution. The absence of control groups across most included studies precludes causal inference, and the diversity of PROMs used across studies introduces further methodological variability. In conclusion, BCHDs represent a robust, life-changing rehabilitative strategy for adult COM patients, offering a superior alternative when traditional surgical restoration is unsuccessful.

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Supplementary material

The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fauot.2026.1798374/full#supplementary-material

Supplementary material Supplementary material at the source

Footnotes

Edited by: William (Bill) E. Hodgetts, University of Alberta, Canada

Reviewed by: Kuniyuki Takahashi, University of Miyazaki, Japan

Rachael Collins, Norfolk and Norwich University Hospital NHS Foundation Trust, United Kingdom

Footnotes

APHAB, Abbreviated Profile of Hearing Aid Benefit; BAHA, Bone-Anchored Hearing Aid; BCHD/BCHDs, Bone Conduction Hearing Device(s); BCI, Bone Conduction Implant; BTE, Behind-the-Ear; CHL, Conductive Hearing Loss; COM, Chronic Otitis Media; CSOM, Chronic Suppurative Otitis Media; GBI, Glasgow Benefit Inventory; GHSI, Glasgow Health Status Inventory; HRQoL, Health-Related Quality of Life; HUI-3, Health Utilities Index Mark 3; LMIC, Low- and Middle-Income Country; MHL, Mixed Hearing Loss; MPO, Maximum Power Output; MRI, Magnetic Resonance Imaging; NOS, Newcastle-Ottawa Scale; PRISMA, Preferred Reporting Items for Systematic Reviews and Meta-Analyses; PROM, Patient-Reported Outcome Measure; PTA4, Pure-Tone Average (four-frequency) ; QALY, Quality-Adjusted Life Year; ROBINS-I, Risk of Bias in Non-randomized Studies of Interventions; SNR, Signal-to-Noise Ratio; SSQ, Speech, Spatial and Qualities of Hearing Scale; SSD, Single-Sided Deafness.

Statements

Conflict of interest

XW is a current employee of Cochlear Limited, a manufacturer and supplier of implantable hearing devices.

The remaining author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Funding

The author(s) declared that financial support was not received for this work and/or its publication.

Data availability

The original contributions presented in the study are included in the article/Supplementary material, further inquiries can be directed to the corresponding authors.

Ethics approval

The studies involving humans were approved by Per PRISMA and Cochrane guidelines, systematic reviews synthesizing published data typically bypass de novo ethics approval. Nonetheless, to uphold patient safeguards and data quality, only studies with documented Ethics Committee/IRB clearance and explicit informed consent procedures were eligible (Sterne et al., 2016). All included studies complied with the Declaration of Helsinki and received ethic committee approval. The studies were conducted in accordance with the local legislation and institutional requirements. Written informed consent for participation was not required from the participants or the participants' legal guardians/next of kin in accordance with the national legislation and institutional requirements.

Author contributions

XW: Data curation, Formal analysis, Methodology, Project administration, Writing – original draft, Writing – review & editing. WL: Data curation, Writing – review & editing. JM: Data curation, Formal analysis, Methodology, Supervision, Writing – review & editing.

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Citation

Wang, X., et al. (2026). Impact of bone conduction hearing devices on health-related quality of life in chronic otitis media-related hearing loss: a systematic review and meta-analysis. Frontiers in Audiology and Otology, Volume 4. https://doi.org/
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4 - 2026

Copyright

Copyright © 2026 Wang, Li and Miao Jonasson.

License: https://creativecommons.org/licenses/by/4.0/

*Correspondence: Xing Wang; Junmei Miao Jonasson

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