| 1. |
- Fredén Jansson, Karl-Johan, 1988, et al.
(författare)
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Magnetic resonance imaging investigation of the bone conduction implant - a pilot study at 1.5 Tesla.
- 2015
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Ingår i: Medical devices (Auckland, N.Z.). - 1179-1470. ; 8, s. 413-23
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Tidskriftsartikel (refereegranskat)abstract
- The objective of this pilot study was to investigate if an active bone conduction implant (BCI) used in an ongoing clinical study withstands magnetic resonance imaging (MRI) of 1.5 Tesla. In particular, the MRI effects on maximum power output (MPO), total harmonic distortion (THD), and demagnetization were investigated. Implant activation and image artifacts were also evaluated.
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| 2. |
- Fredén Jansson, Karl-Johan, 1988, et al.
(författare)
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Robustness and lifetime of the bone conduction implant - a pilot study
- 2019
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Ingår i: Medical Devices: Evidence and Research. - 1179-1470. ; 12, s. 89-100
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The objective of this study was to develop methods for evaluating the mechanical robustness and estimating the lifetime of the novel bone conduction implant (BCI) that is used in a clinical study. The methods are intended to be applicable to any similar device. Materials and methods: The robustness was evaluated using tests originally developed for cochlear implants comprising a random vibration test, a shock test, a pendulum test, and an impact test. Furthermore, magnetically induced torque and demagnetization during magnetic resonance imaging at 1.5 T were investigated using a dipole electromagnet. To estimate the lifetime of the implant, a long-term age-accelerated test was performed. Results: Out of all the tests, the pendulum and the impact tests had the largest effect on the electro-acoustic performance of the BCI implant, even if the change in performance was within acceptable limits (< 20%). In comparison with baseline data, the lower and higher resonance peaks shifted down in frequency by 13% and 18%, respectively, and with a loss in magnitude of 1.1 and 2.0 dB, respectively, in these tests. Conclusion: A complete series of tests were developed, and the BCI passed all the tests; its lifetime was estimated to be at least 26 years for patients who are using the implant for 12 hours on a daily basis.
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| 3. |
- Håkansson, Bo, 1953, et al.
(författare)
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The bone conduction implant - a review and 1-year follow-up
- 2019
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Ingår i: International Journal of Audiology. - : Informa UK Limited. - 1499-2027 .- 1708-8186. ; 58:12, s. 945-955
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The objective of this study is to evaluate its safety and effectiveness of the bone conduction implant (BCI) having an implanted transducer and to review similar bone conduction devices. Design: This is a consecutive prospective case series study where the patients were evaluated after 1, 3, 6 and 12 months. Outcome measures were focussed on intraoperative and postoperative safety, the effectiveness of the device in terms of audiological performance and patient's experience. Study sample: Sixteen patients with average age of 40.2 (range 18-74) years have been included. Thirteen patients were operated in Gothenburg and three in Stockholm. Results: It was found that the procedure for installing the BCI is safe and the transmission condition was stable over the follow-up time. No serious adverse events or severe adverse device effects occurred. The hearing sensitivity, speech in noise and the self-assessment as compared with the unaided condition improved significantly with the BCI. These patients also performed similar or better than with a conventional bone conduction reference device on a softband. Conclusions: In summary, it was found that the BCI can provide a safe and effective hearing rehabilitation alternative for patients with mild-to-moderate conductive or mixed hearing impairments.
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| 4. |
- Håkansson, Bo, 1953, et al.
(författare)
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VEMP using a new low-frequency bone conduction transducer
- 2018
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Ingår i: Medical Devices: Evidence and Research. - 1179-1470. ; 11, s. 301-312
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Tidskriftsartikel (refereegranskat)abstract
- Objective: A new prototype bone conduction (BC) transducer B250, with an emphasized low-frequency response, is evaluated in vestibular evoked myogenic potential (VEMP) investigations. The aim was to compare cervical (cVEMP) and ocular (oVEMP) responses using tone bursts at 250 and 500 Hz with BC stimulation using the B250 and the conventional B81 transducer and by using air conduction (AC) stimulation. Methods: Three normal subjects were investigated in a pilot study. BC stimulation was applied to the mastoids in cVEMP, and both mastoid and forehead in oVEMP investigations. Results: BC stimulation was found to reach VEMP thresholds at considerably lower hearing levels than in AC stimulation (30-40 dB lower oVEMP threshold at 250 Hz). Three or more cVEMP and oVEMP responses at consecutive 5 dB increasing mastoid stimulation levels were only obtained in all subjects using the B250 transducer at 250 Hz. Similar BC thresholds were obtained for both ipsilateral and contralateral mastoid stimulation. Forehead stimulation, if needed, may require a more powerful vibration output. Conclusion: Viable VEMP responses can be obtained at a considerably lower hearing level with BC stimulation than by AC stimulation. The cVEMP and oVEMP responses were similar when measured on one side and with the B250 attached to both ipsilateral and contralateral mastoids.
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| 5. |
- Persson, Ann-Charlotte, 1970, et al.
(författare)
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Three-Year Follow-Up with the Bone Conduction Implant
- 2020
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Ingår i: Audiology and Neuro-Otology. - : S. Karger AG. - 1421-9700 .- 1420-3030. ; 25:5, s. 263-275
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Tidskriftsartikel (refereegranskat)abstract
- Background: The bone conduction implant (BCI) is an active transcutaneous bone conduction device where the transducer has direct contact to the bone, and the skin is intact. Sixteen patients have been implanted with the BCI with a planned follow-up of 5 years. This study reports on hearing, quality of life, and objective measures up to 36 months of follow-up in 10 patients. Method: Repeated measures were performed at fitting and after 1, 3, 6, 12, and 36 months including sound field warble tone thresholds, speech recognition thresholds in quiet, speech recognition score in noise, and speech-to-noise thresholds for 50% correct words with adaptive noise. Three quality of life questionnaires were used to capture the benefit from the intervention, appreciation from different listening situations, and the ability to interact with other people when using the BCI. The results were compared to the unaided situation and a Ponto Pro Power on a soft band. The implant functionality was measured by nasal sound pressure, and the retention force from the audio processor against the skin was measured using a specially designed audio processor and a force gauge. Results: Audiometry and quality of life questionnaires using the BCI or the Ponto Pro Power on a soft band were significantly improved compared to the unaided situation and the results were statistically supported. There was generally no significant difference between the two devices. The nasal sound pressure remained stable over the study period and the force on the skin from the audio processor was 0.71 ± 0.22 N (mean ± 1 SD). Conclusion: The BCI improves the hearing ability for tones and speech perception in quiet and in noise for the indicated patients. The results are stable over a 3-year period, and the patients subjectively report a beneficial experience from using the BCI. The transducer performance and contact to the bone is unchanged over time, and the skin area under the audio processor remains without complications during the 3-year follow-up.
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| 6. |
- Reinfeldt, Sabine, 1978, et al.
(författare)
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Nasal sound pressure as objective verification of implant in active transcutaneous bone conduction devices
- 2019
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Ingår i: Medical Devices: Evidence and Research. - 1179-1470. ; 12, s. 193-202
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Active transcutaneous bone conduction devices consist of an external audio processor and an internal implant under intact skin. During the surgical procedure, it is important to verify the functionality of the implant before the surgical wound is closed. In a clinical study with the new bone conduction implant (BCI), the functionality of the implant was tested with an electric transmission test, where the output was the nasal sound pressure (NSP) recorded in the ipsilateral nostril. The same measurement was performed in all follow-up visits to monitor the implant's functionality and transmission to bone over time. The objective of this study was to investigate the validity of the NSP method as a tool to objectively verify the implant's performance intraoperatively, as well as to follow-up the implant's performance over time. Design: Thirteen patients with the BCI were included, and the NSP measurement was part of the clinical study protocol. The implant was electrically stimulated with an amplitude-modulated signal generator using a swept sine 0.1-10 kHz. The NSP was measured with a probe tube microphone in the ipsilateral nostril. Results: The NSP during surgery was above the noise floor for most patients within the frequency interval 0.4-5 kHz, showing NSP values for expected normal transmission of a functioning implant. Inter-subject comparison showed large variability, but follow-up results showed only minor variability within each subject. Further investigation showed that the NSP was stable over time. Conclusion: The NSP method is considered applicable to verify the implant's functionality during and after surgery. Such a method is important for implantable devices, but should be simplified and clinically adapted. Large variations between subjects were found, as well as smaller variability in intra-subject comparisons. As the NSP was found to not change significantly over time, stable transmission to bone, and implant functionality, were indicated.
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| 7. |
- Rigato, Cristina, 1989, et al.
(författare)
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Audiometric comparison between Bone Anchored Hearing Aid and Bone Conduction Implant
- 2016
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Ingår i: AudiologyNOW!2016.
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Konferensbidrag (övrigt vetenskapligt/konstnärligt)abstract
- Patients suffering from conductive or mixed hearing losses can often be successfully rehabilitated using bone conduction devices (BCDs). Percutaneous BCDs are widely used today, but the trend is to develop transcutaneous solutions able to providing equally good rehabilitation and less complications. Here, the transcutaneous Bone Conduction Implant was compared with percutaneous BCDs under the hypothesis that they are equally effective. Tone and speech audiometry and questionnaires were utilized to assess the overall performance. The outcome confirmed the initial hypothesis.
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| 8. |
- Rigato, Cristina, 1989, et al.
(författare)
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Audiometric Comparison Between the First Patients With the Transcutaneous Bone Conduction Implant and Matched Percutaneous Bone Anchored Hearing Device Users
- 2016
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Ingår i: Otology & Neurotology. - : Ovid Technologies (Wolters Kluwer Health). - 1531-7129 .- 1537-4505. ; 37:9, s. 1381-1387
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Tidskriftsartikel (refereegranskat)abstract
- Hypothesis:The transcutaneous bone conduction implant (BCI) is compared with bone-anchored hearing aids (BAHAs) under the hypothesis that the BCI can give similar rehabilitation from an audiological as well as patient-related point of view.Background:Patients suffering from conductive and mixed hearing losses can often benefit more from rehabilitation using bone conduction devices (BCDs) rather than conventional air conduction devices. The most widely used BCD is the percutaneous BAHA, with a permanent skin-penetrating abutment. To overcome issues related to percutaneous BCDs, the trend today is to develop transcutaneous devices, with intact skin. The BCI is an active transcutaneous device currently in a clinical trial phase. A potential limitation of active transcutaneous devices is the loss of power in the induction link over the skin. To address this issue, countermeasures are taken in the design of the BCI, which is therefore expected to be as effective as percutaneous BCDs.Methods:An early observational study with a matched-pair design was performed to compare BCI and BAHA groups of patients over several audiometric measurements, including speech audiometry and warble tones thresholds with and without the device. Additionally, questionnaires were used to assess the general health condition, benefit, and satisfaction level of patients.Results:No statistically significant difference was detected in any of the audiological measurements. The outcome of patient-related measurements was slightly superior for BCI in all subscales.Conclusion:Results confirm the initial hypothesis of the study: the BCI seems to be capable of providing as good rehabilitation as percutaneous devices for indicated patients.
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| 9. |
- Rigato, Cristina, 1989, et al.
(författare)
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Audiometric comparison in BCI and BAHA matched patients
- 2015
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- Purpose: Patients that are suffering from outer or middle ear hearing impairment can often benefit more from rehabilitation using bone conduction devices (BCDs) rather than conventional air conduction devices. The most widely used BCD is the percutaneous Bone Anchored Hearing Aid (BAHA), which gives excellent sound, but can cause side effects from the skin penetration abutment. There is a growing interest in the development of transcutaneous BCDs such as the Bone Conduction Implant (BCI), comprising an externally worn audio processor wirelessly driving a transducer implanted in the temporal bone. In an ongoing clinical study, the device is used in six patients and the objective with this study is to compare their audiometric results with patients using the BAHA.Methods & Materials: Audiometric measurements are currently carried out on patients using a BAHA (Ponto Pro Power, Oticon Medical) that are matched one by one according to age- and hearing loss-based criteria with the six first patients treated with the BCI. In particular, warble tone thresholds, speech recognition score (SRS) in noise, speech recognition threshold (SRT) and signal-to-noise ratio (SNR) threshold are compared in a sound field. The patients’ general health status and personal satisfaction is also evaluated using Glasgow Benefit Inventory and Abbreviated Profile of Hearing Aid Benefit questionnaires. Furthermore, maximum power output and total harmonic distortion are measured for each device on a skullsimulator.Results: The study is on-going and detailed results will be presented. Preliminary results from two patients tested with the BAHA indicate that they generally perform the same or slightly worse than matched patients with BCI regarding warble tone thresholds, SRS, SRT and SNR threshold. The self-reported questionnaires show in general similar outcome for both devices, but slightly better results for BCI compared with the BAHA concerning physical benefit and avoidance of negative reactions to unpleasant sounds.Conclusion: Preliminary results from audiometric measurements show a clear improvement over the unaided condition for both devices, and indicate that the BCI is equal or slightly better
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| 10. |
- Rigato, Cristina, 1989, et al.
(författare)
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Audiometric results of the Bone Conduction Implant: a comparative study with the Bone Anchored Hearing Aid
- 2015
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Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
- Background:Patients suffering from conductive-, sensorineural- or mixed hearing loss that are unable to use conventional air conduction hearing aids, can often be rehabilitated with bone conduction devices (BCDs) . The most widely used BCD is the percutaneous Bone Anchored Hearing Aid (BAHA), which gives excellent sound but has some known complications related to the side effects from the skin penetration. In order to overcome such issues, the development of transcutaneous BCDs has increased. Among them, the Bone Conduction Implant (BCI) is an active BCD developed in Gothenburg, Sweden. It comprises an externally worn audio processor unit which is magnetically attached to an implanted unit to wirelessly drive a transducer in the temporal bone. The device is currently implanted in six patients in the clinical trial phase and the objective with this study is to compare the BCI and BAHA devices.Methods:Audiometric measurements are currently carried out on BCI and BAHA patients matched one by one according to age- and hearing loss-based criteria. In particular, pure tones hearing thresholds, speech recognition threshold (SRT) in quiet and speech recognition score (SRS) in noise are compared as well as signal to noise ratio (SNR). In addition, maximum power output (MPO) and total harmonic distortion (THD) are measured for each device on a skullsimulator in an anechoic chamber. The patients’ satisfaction and general health condition are also evaluated by means of questionnaires. Results:Results from three patients tested with the BAHA indicate that they generally perform as or slightly worse than matched patients with BCI in all tested audiometric measurements. The self-reported questionnaires show in general similar outcome for both devices, with slightly better results for BCI compared with the BAHA concerning physical benefit and avoidance of negative reactions to unpleasant sounds.Conclusions:Results from audiometric measurements show a clear improvement over the unaided condition for both devices, and indicate that the BCI is equal or slightly better than the BAHA. As this is a pilot study currently ongoing, the results may change when all six BCI patients have been matched with a BAHA patient.
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