| Cochrane review (Ferguson et al. 2017) |
| Hearing aids for mild to moderate adult hearing loss improve hearing-specific and general health-related quality of life and listening ability (5 RCTs, 825 participants); supports first-line provision of hearing aids. |
| Systematic reviews / studies for BAHA / Bone conduction devices |
| Multiple systematic reviews and observational studies report audiological benefits (improved speech discrimination in noise, improved thresholds), variable effects on localization, and generally low-to-weak quality evidence but overall reasonable support for BAHA in conductive/mixed loss and SSD indications. |
| Earlens clinical trials (Gantz 2017; Arbogast 2019) |
| Single-arm trials and multicenter studies showed safety and significant functional gain and improved word recognition/APHAB scores (e.g., 28–32 percentage point APHAB improvements vs unaided); FDA de novo/510(k) clearance supported by these data. |
| Totally implantable middle ear devices (Carina, Esteem) - reviews and cohort studies |
| Evidence limited and mixed: some studies report functional gain and improved speech measures but substantial device-specific complications, failures, explants, and inconsistent results; overall quality low and insufficient for broad conclusions. |
| Intraoral (SoundBite) studies |
| Case series and small crossover studies in SSD report improved APHAB and patient satisfaction; device manufacturing ceased after 2015; evidence low quality with selection bias and limited follow-up. |
| Partially implantable bone conduction devices (e.g., BAHA Attract, Bonebridge, Osia, Sophono) |
| Systematic reviews and cohort studies report improved audiological outcomes, high patient satisfaction, and low-to-moderate complication rates, but long-term comparative randomized data are lacking and evidence quality often low to very low. |
| Systematic reviews / HTAs (AAO-HNS, ECRI, Hayes, Ontario Health) |
| Professional society statements and HTAs conclude bone conduction and active middle ear implants are appropriate for selected patients (conductive/mixed loss, SSD, or when conventional aids insufficient), noting available FDA clearances and need for adherence to indications; HTAs report likely improvements in thresholds, speech perception and hearing-specific QoL versus no intervention. |
| Non-implantable bone-conduction devices and headband/softband studies (softband, ADHEAR, BAHA SoundArc) |
| Prospective and cohort studies show significant aided threshold and speech audiometry improvements in children and adults; ADHEAR and softband provide comparable benefits to passive implants for selected patients and are options when surgery is not desired. |
| Meta-analyses / systematic reviews of active transcutaneous and passive transcutaneous devices (Magele 2019; Cooper & McDonald 2017; Dimitriadis 2016) |
| Reviews report beneficial audiological performance and high satisfaction with active transcutaneous devices, low major complication rates, and favorable functional gain, but evidence limited to cohort studies and case series. |
| BAHA bilateral vs unilateral reviews (Janssen, Colquitt) |
| Observational studies suggest bilateral BAHA can provide additional audiologic benefit (improved thresholds, speech in quiet/noise) though evidence is weak and caution advised in interpretation. |
| FDA clearance and device-specific regulatory references |
| Multiple devices (Vibrant Soundbridge, Maxum, BAHA models, Bonebridge, Osia, Earlens, SoundBite, Esteem) have FDA clearances/approvals with device-specific labeled indications and audiologic selection criteria cited in the regulatory documentation. |