Guideline “Implantable hearing aids”—short version

Beutner, Dirk; Delb, W.; Frenzel, H; Hoppe, Ulrich; Hüttenbrink, K.-B.; Mlynski, Robert; Limberger, Annette; Schönweiler, R.; Schwab, Burkard; Todt, Ingo; Walger, Martin; Wesarg, Thomas; Zahnert, Thomas; Zeh, Roland; Adano,; Dghno,; Dcig, Deutsche Cochlea Implantat Gesellschaft; Dgpp,

doi:10.1007/s00106-018-0533-2

Cited by 24 publications

(11 citation statements)

References 34 publications

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“…The BoneBridge (BB; MED-EL, Innsbruck, Austria) is an active transcutaneous bone-conduction implant (BCI) consisting of an external processor that directly generates vibrations in an implanted segment via electromagnetism or piezoelectricity (1). Currently, the BB is indicated for conductive hearing loss (CHL) or mixed hearing loss (MHL) with bone-conduction (BC) thresholds of 45 dB HL or better, as a contralateral routing device in cases of single-sided deafness (SSD), for insufficient hearing rehabilitation after multiple tympanoplasties or mastoidectomy, and for cases when conventional hearing rehabilitation is not possible (2). Two editions of the BB exist-the first-generation BCI 601 and second-generation BCI 602.…”

Section: Introductionmentioning

confidence: 99%

Outcomes After Transcutaneous Bone-Conduction Implantation in Adults and Children

et al. 2023

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ObjectiveTo evaluate clinical and audiometric outcomes of adult and pediatric patients implanted with a semi-implantable transcutaneous active bone-conduction implant.Study DesignRetrospective chart review.SettingTwo tertiary referral centers.PatientsSubjects implanted with the semi-implantable transcutaneous active bone-conduction implant called BoneBridge.InterventionImplantation of the BoneBridge and audiometric evaluations.Main Outcome MeasuresAudiometric, clinical, and surgical outcomes as well as complications.ResultsForty-two adults and 20 children were implanted for conductive or mixed hearing loss as well as single-sided deafness. Implantation significantly improved mean air-conduction pure-tone average from 72.8 ± 22.3 to 35 ± 9 dB in adults and from 65.7 ± 24.3 to 19.6 ± 8.2 dB in children (both p < 0.001). Word recognition score improved from 63.7 ± 38.8% to 85.6 ± 10.6% in adults and 57.8 ± 38% to 89.3 ± 10.1% in children (both p < 0.05). The rate of revision surgery was 11.3%, with four patients (6.5%) undergoing removal for device-related complications, two (3.2%) for complications associated with implantation, and one (1.6%) for device failure secondary to external trauma.ConclusionsIn a large retrospective series consisting of both pediatric and adult patients, implantation with a transcutaneous active bone-conduction implant was found to be a reliable aural rehabilitation option for a variety of hearing loss etiologies.

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Section: Introductionmentioning

confidence: 99%

Outcomes After Transcutaneous Bone-Conduction Implantation in Adults and Children

et al. 2023

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“…Following the manufacturer's guidelines, the Bonebridge is indicated for the following: conductive or mixed hearing loss with BC thresholds ≤ 45 dB HL (4PTA BC ); as a contralateral routing device in cases of SSD; with insufficient hearing rehabilitation after (multiple) tympanoplasty; after canal wall down mastoidectomy; in otitis media and externa, when conventional hearing rehabilitation is not possible; and in malformations [1,8]. In the European Union, the device is CE-approved for patients age 5 years and older.…”

Section: Introductionmentioning

confidence: 99%

Clinical and functional results after implantation of the bonebridge, a semi-implantable, active transcutaneous bone conduction device, in children and adults

Seiwerth

Fröhlich

Schilde

et al. 2021

Eur Arch Otorhinolaryngol

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Purpose Aim of the study was to evaluate the surgical, clinical and audiological outcome of 32 implantations of the Bonebridge, a semi-implantable transcutaneous active bone conduction implant. Methods In a retrospective cohort study, we analyzed data for 32 implantations in 31 patients (one bilateral case; seven age < 16 years) with conductive or mixed hearing loss, malformations, after multiple ear surgery, or with single-sided deafness as contralateral routing of signal (CROS). Results Four implantations were done as CROS. Five cases were simultaneously planned with ear prosthesis anchors, and 23 implantations (72%) were planned through three-dimensional (3D) “virtual surgery.” In all 3D-planned cases, the implant could be placed as expected. For implant-related complications, rates were 12.5% for minor and 3.1% for major complications. Implantation significantly improved mean sound field thresholds from a preoperative 60 dB HL (SD 12) to 33 dB HL (SD 6) at 3 postoperative months and 34 dB HL (SD 6) at > 11 postoperative months (p < 0.0001). Word recognition score in quiet at 65 dB SPL improved from 11% (SD 20) preoperatively to 74% (SD 19) at 3 months and 83% (SD 15) at > 11 months (p < 0.0001). The speech reception threshold in noise improved from − 1.01 dB unaided to − 2.69 dB best-aided (p = 0.0018). Conclusion We found a clinically relevant audiological benefit with Bonebridge. To overcome anatomical challenges, we recommend preoperative 3D planning in small and hypoplastic mastoids, children, ear malformation, and simultaneous implantation of ear prosthesis anchors and after multiple ear surgery.

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“…Active middle ear implants (AMEIs) have become an appropriate solution for hearing rehabilitation in patients with moderate to severe sensorineural or mixed hearing loss who cannot use conventional hearing aids due to technical issues such as feedback or sound distortion, or patient-related issues like recurrent infections of the auditory canal [ 1 ]. The Vibrant Soundbridge (VSB) (MED-EL, Innsbruck, Austria) is a frequently used AMEI which transforms airborne sound into mechanical vibrations by its miniature floating mass transducer (FMT) [ 2 , 3 ].…”

Section: Introductionmentioning

confidence: 99%

Intraoperative quantification of floating mass transducer coupling quality in active middle ear implants: a multicenter study

Fröhlich

Rahne

Plontke

et al. 2020

Eur Arch Otorhinolaryngol

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Purpose Evaluating the effectiveness of intraoperative auditory brainstem responses (ABRs) to stimulation by the Vibrant Soundbridge (VSB) active middle ear implant for quantifying the implant's floating mass transducer (FMT) coupling quality. Methods In a diagnostic multicentric study, patients (> 18 years) who received a VSB with different coupling modalities were included. Pre-and postoperative bone conduction thresholds, intraoperative VSB-evoked ABR thresholds (VSB-ABR) using a modified audio processor programmed to preoperative bone conduction thresholds, postoperative vibrogram thresholds, and postoperative VSB-ABR thresholds were measured. Coupling quality was calculated from the difference between the pure tone average at 1000, 2000, and 4000 Hz (3PTA) vibrogram and postoperative 3PTA bone conduction thresholds. Results Twenty-three patients (13 males, 10 females, mean age 56.6 (± 12.5) years) were included in the study. Intraoperative VSB-ABR response thresholds could be obtained in all except one patient where the threshold was > 30 dB nHL. Postoperatively, an insufficient coupling of 36.7 dB was confirmed in this patient. In a Bland-Altman analysis of the intraoperative VSB-ABRs and coupling quality, the limits of agreement exceeded ± 10 dB, i.e., the maximum allowed difference considered as not clinically important but the variation was within the general precision of auditory brainstem responses to predict behavioral thresholds. Five outliers were identified. In two patients, the postoperative VSB-ABR thresholds were in agreement with the coupling quality, indicating a change of coupling before the postoperative testing. Conclusion The response thresholds recorded in this setup have the potential to predict the VSB coupling quality and optimize postoperative audiological results.

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Guideline “Implantable hearing aids”—short version

Cited by 24 publications

References 34 publications

Outcomes After Transcutaneous Bone-Conduction Implantation in Adults and Children

Outcomes After Transcutaneous Bone-Conduction Implantation in Adults and Children

Clinical and functional results after implantation of the bonebridge, a semi-implantable, active transcutaneous bone conduction device, in children and adults

Intraoperative quantification of floating mass transducer coupling quality in active middle ear implants: a multicenter study

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