Evidence map›Paper›PMID 41247283›Full record

ArticleOtology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology2026

A Prospective, Multicenter Clinical Investigation on the Safety and Performance of a New Active Transcutaneous Bone-Anchored Implant System.

Myrthe Karianne Sophie Hol, Tjerk Winus Aukema, Sander Wilhelmus Johannes Ubbink, Dennis Lindholm, Marcus Holmberg, Susan Arndt, Stefanie Wolf, Peter Monksfield, Mihalache Marwa, Thomas Lenarz and 5 more

Abstract readClinical StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

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

  1. Guideline
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Myrthe Karianne Sophie HolDepartment of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Groningen, Graduate School of Medical Sciences, Research School of Behavioural and Cognitive Neuroscience, University of Groningen, Groningen, The Netherlands.ORCID 0000-0002-9708-935
Tjerk Winus AukemaDepartment of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Groningen, Graduate School of Medical Sciences, Research School of Behavioural and Cognitive Neuroscience, University of Groningen, Groningen, The Netherlands.
Sander Wilhelmus Johannes UbbinkDepartment of Otorhinolaryngology and Head and Neck Surgery, University Medical Center Groningen, Graduate School of Medical Sciences, Research School of Behavioural and Cognitive Neuroscience, University of Groningen, Groningen, The Netherlands.
Dennis LindholmOticon Medical AB, Askim, Sweden.
Marcus HolmbergOticon Medical AB, Askim, Sweden.
Susan ArndtDepartment of Otorhinolaryngology and Head and Neck Surgery, Universitätsklinikum Freiburg, Breisgau, Germany.
Stefanie WolfDepartment of Otorhinolaryngology and Head and Neck Surgery, Universitätsklinikum Freiburg, Breisgau, Germany.
Peter MonksfieldDepartment of Otorhinolaryngology and Head and Neck Surgery, University Hospitals Birmingham (Queen Elizabeth Hospital), Birmingham, UK.
Mihalache MarwaDepartment of Otorhinolaryngology and Head and Neck Surgery, University Hospitals Birmingham (Queen Elizabeth Hospital), Birmingham, UK.
Thomas LenarzDepartment of Otorhinolaryngology and Head and Neck Surgery, Medizinische Hochschule Hannover, Hanover, Germany.
Susan BuschDepartment of Otorhinolaryngology and Head and Neck Surgery, Medizinische Hochschule Hannover, Hanover, Germany.
James TysomeDepartment of Otorhinolaryngology and Head and Neck Surgery, Cambridge University Hospitals (Addenbrooke's Hospital), Cambridge, UK.
Abi AsherDepartment of Otorhinolaryngology and Head and Neck Surgery, Cambridge University Hospitals (Addenbrooke's Hospital), Cambridge, UK.
Herman KokDepartment of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Donders Center for Neuroscience, Radboud University, Nijmegen, The Netherlands.
Maria Mylanus Emmanuel AntoniusDepartment of Otorhinolaryngology and Head and Neck Surgery, Radboud University Medical Center, Donders Center for Neuroscience, Radboud University, Nijmegen, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate safety and performance of a new active transcutaneous system, 3 and 6 months postoperatively. STUDY

designAn open, prospective, multicenter clinical investigation with 24-month follow-up.

settingSix European tertiary referral centers from the Netherlands, Germany, and United Kingdom. PATIENTS: Fifty-one adult patients with conductive hearing loss, mixed hearing loss, or single-sided deafness requiring surgical intervention for bone conduction hearing.

interventionImplantation and fitting of an active transcutaneous device, the Sentio System.

main outcome measurePerformance outcomes included variables related to surgery (eg, surgery time and postoperative wound healing), audiology (eg, sound field thresholds, speech recognition in quiet and noise), and patient-reported outcomes (eg, quality of life, intervention benefit, and patient satisfaction). Moreover, safety was assessed by continuous reporting of adverse events and serious adverse events.

resultsSmooth implant installation with no or limited preoperative imaging, and without major events in the postoperative phase was demonstrated. Audiological assessments showed significant improvements in sound field thresholds, with a mean functional gain of 32.8 dB (PTA4) and a mean effective gain of 9.0 dB. Mean aided speech recognition in quiet was 97.9%, and the improvement in speech-noise-ratio compared with a sound processor on softband was -2.98 dB. The patients reported a high perceived quality of life, with 96.1% reporting improvements post-intervention. Safety was confirmed by a limited amount and mild nature of adverse events. DISCUSSION: The Sentio system provides a safe and effective treatment option, showing significant improvements in hearing outcomes, patient benefits, and quality of life for patients.

Indexed as

Bone-Anchored ProsthesisHearing Loss, ConductiveHearing Loss, Mixed Conductive-SensorineuralAdultAgedBone ConductionFemaleHearing AidsHumansMaleMiddle AgedPatient SatisfactionProspective StudiesQuality of LifeSpeech PerceptionTreatment OutcomeActive transcutaneousAudiometryBone conduction implantConductive and mixed hearing lossPatient reported outcomesSafetySingle-sided deafness

Identifiers

PMID41247283
PMCPMC12777597

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.