ArticleOtology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology2020
Multicenter Clinical Investigation of a New Active Osseointegrated Steady-State Implant System.
Article in Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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 28 papers, 1 of them a synthesis that pooled 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.
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.
OSIA System Bilateral Implantation Efficacy Evaluation in Children With Ear Aplasia
Who cites it
28 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Systematic Review of Quality of Life in Bone Anchored Hearing: Conductive vs. Unilateral Sensorineural Hearing Loss.The Laryngoscope · 2025Pooled it
- Audiological Characteristics in Vestibular Schwannoma Patients.World journal of otorhinolaryngology - head and neck surgery · 2026Article
- Cost-effectiveness Analysis Comparing Osia System to Percutaneous Bone Conduction Devices in Sweden.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2026Article
- A Prospective, Multicenter Clinical Investigation on the Safety and Performance of a New Active Transcutaneous Bone-Anchored Implant System.Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2026Article
- A cost-utility analysis of the transcutaneous Osia System® compared to the percutaneous bone-conduction hearing implant Baha® Connect for hearing loss in Spain.Frontiers in public health · 2026Article
- Comparison of Different Surgical Techniques for OsiaJournal of clinical medicine · 2025Article
- Long-term outcomes of tympanoplasty with persistent air-bone gap in adults with chronic otitis media: hearing, health care utilization and quality of life.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 · 2025Article
- Hearing Rehabilitation with OsiaYonsei medical journal · 2025Article
- Risk Factors in the Formation of Congenital Malformations of the Ear: Microtia and Atresia of the External Auditory Canal.Journal of clinical medicine research · 2025Article
- The Ponto Bone-Anchored Hearing System - Benefits Following Radical Mastoidectomy.Medical science monitor : international medical journal of experimental and clinical research · 2025Article
- 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 · 2025Article
- 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 · 2024Article
- Auditory and Speech Outcomes Following Transcutaneous Bone Conduction Hearing Implantation.Cureus · 2024Article
- A MAUDE database analysis on the new generation of active bone conduction hearing implants.Laryngoscope investigative otolaryngology · 2024Article
- Article
- Comparative Clinical Effectiveness and Cost-Effectiveness of the Cochlear Osia System and Baha Attract System in Patients with Conductive or Mixed Hearing Loss or Single-Sided Deafness.Journal of market access & health policy · 2024Article
- Article
- [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 · 2023Review
- The Role of Bone-Anchored Hearing Devices and Remote Microphones in Children with Congenital Unilateral Hearing Loss.Brain sciences · 2023Article
- How I do it: Cochlear Osia 2 System surgery placement.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 · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveA new active transcutaneous bone conduction hearing implant system that uses piezoelectric technology has been developed: an active osseointegrated steady-state implant system (OSI). This was the first clinical investigation undertaken to demonstrate clinical performance, safety, and benefit of the new implant system. STUDY DESIGN AND
settingA multicenter prospective within-subject clinical investigation was conducted. PATIENTS: Fifty-one adult subjects with mixed and conductive hearing loss (MHL/CHL, n = 37) and single-sided sensorineural deafness (SSD, n = 14) were included.
main outcome measureAudiological evaluations included audiometric thresholds, speech recognition in noise, and quiet. Hearing and health-related patient-reported outcomes (PROs; health utilities index [HUI], abbreviated profile of hearing aid benefit [APHAB], and speech, spatial of qualities of hearing scale [SSQ]), daily use, surgical and safety parameters were collected.
resultsIntra- and postoperative complications were few. One implant was removed before activation due to post-surgical infection. Compared with the preoperative softband tests, a significant improvement in speech recognition-in-noise was observed in the MHL/CHL group (-7.3 dB, p ≤ 0.0001) and the SSD group (-8.1 dB, p = 0.0008). In quiet, word recognition improved in the MHL/CHL group, most markedly at lower intensity input of 50 dB SPL (26.7%, p ≤ 0.0001). The results of all PROs showed a significant improvement with the new device compared with preoperative softband in the MHL/CHL group. In the SSD group significant improvements were observed in the APHAB and SSQ questionnaires. DISCUSSION: The results confirmed the clinical safety, performance, and benefit of this new treatment modality for subjects with CHL, MHL, and SSD.
Indexed as
Identifiers
What OpenQuestion holds
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.