Evidence map›Paper›PMID 34792628›Full record

ArticleEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery2022

Long-term data of the new transcutaneous partially implantable bone conduction hearing system Osia®.

Ann-Kathrin Rauch, Thomas Wesarg, Antje Aschendorff, Iva Speck, Susan Arndt

Erratum issued Registry-linked trialAbstract read
In one paragraph

Article in European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT07358728 (OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07358728 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2026 to 2029Enrolled12ConditionsDeafness Caused by High Grade Microtia or Ear AtresiaArmsAudiological tests, Speech, Spatial and Qualities of Hearing Scale
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. Patient-reported outcomes and speech-in-noise performance with OSIA versus other transcranial devices in unilateral and asymmetric hearing loss.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
    Article
  4. Article
  5. Comparison of Different Surgical Techniques for OsiaJournal of clinical medicine · 2025
    Article
  6. Hearing Rehabilitation with OsiaYonsei medical journal · 2025
    Article
  7. Active piezoelectric bone conduction implant OsiaEuropean archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025
    Article
  8. Bone-conduction Hearing Aids: A Scoping Review.Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India · 2024
    Article
  9. Article
  10. Article
  11. A Rare Case of Osia Extrusion. Our Management Proposal.Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India · 2024
    Article
  12. Article
  13. Clinical performance, safety, and patient-reported outcomes of an active osseointegrated bone-conduction hearing implant system at 24-month follow-up.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
    Article
  14. Article
  15. [Intervention effects of bone conduction hearing aids in patients with single-sided deafness and asymmetric hearing loss].Lin chuang er bi yan hou tou jing wai ke za zhi = Journal of clinical otorhinolaryngology head and neck surgery · 2023
    Review
  16. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Ann-Kathrin RauchDepartment of Oto-Rhino-Laryngology, Medical Center, University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany. ann-kathrin.rauch@uniklinik-freiburg.de.ORCID http://orcid.org/0000-0003-3333-5387
Thomas WesargDepartment of Oto-Rhino-Laryngology, Medical Center, University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany.
Antje AschendorffDepartment of Oto-Rhino-Laryngology, Medical Center, University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany.
Iva SpeckDepartment of Oto-Rhino-Laryngology, Medical Center, University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany.
Susan ArndtDepartment of Oto-Rhino-Laryngology, Medical Center, University of Freiburg, Killianstr. 5, 79106, Freiburg, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe new active transcutaneous partially implantable osseointegrated system Cochlear™ Osia® System is indicated in case of conductive or mixed hearing loss (CHL/MHL) with a maximum average bone conduction hearing loss of 55 dB, or in single-sided deafness (SSD). The implant directly stimulates the bone via a piezoelectric transducer and is directed by an external sound processor. We conducted a monocentric retrospective longitudinal within-subject clinical study at our tertiary academic referral center. The aim was to investigate long-term data (2017-2021) on audiological outcomes and hearing-related quality of life for the Osia system.

methodsBetween 2017 and 2020, 22 adults (18: CHL/MHL; 3: SSD) were implanted with the Osia100 implant; seven received bilateral implants. As of 10/2020, the sound processor was upgraded to Osia 2.

resultsMean Osia system use by 04/2021 was 30.9 ± 8.6 months (range 17-40 months). Unaided bone conduction thresholds were unchanged postoperatively. One patient had to be explanted because of prolonged wound infection. Aided hearing thresholds were significantly lower compared to the unaided thresholds preoperatively, along with a marked increase in speech recognition in quiet. Speech processor upgrade resulted in a stable benefit. Patients with CHL/MHL and SSD showed a similar improvement in self-rated hearing performance revealed by SSQ, APHAB, and HUI questionnaires.

conclusionThe Osia system is a safe, effective and sustainable option for treatment of conductive and mixed hearing loss or single-sided deafness.

Indexed as

DeafnessHearing AidsHearing LossHearing Loss, Mixed Conductive-SensorineuralSpeech PerceptionAdultBone ConductionHearing Loss, ConductiveHumansQuality of LifeRetrospective StudiesTreatment OutcomeActive partially implantable transcutaneous bone conduction implantBone-anchored hearing systemConductive and mixed hearing lossSingle-sided deafness

Identifiers

PMID34792628
PMCPMC9363475

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.