| 1. |
- Clemente, Francesco, et al.
(författare)
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Touch and Hearing Mediate Osseoperception
- 2017
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Ingår i: Scientific Reports. - : Springer Science and Business Media LLC. - 2045-2322. ; 7
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Tidskriftsartikel (refereegranskat)abstract
- Osseoperception is the sensation arising from the mechanical stimulation of a bone-anchored prosthesis. Here we show that not only touch, but also hearing is involved in this phenomenon. Using mechanical vibrations ranging from 0.1 to 6 kHz, we performed four psychophysical measures (perception threshold, sensation discrimination, frequency discrimination and reaction time) on 12 upper and lower limb amputees and found that subjects: consistently reported perceiving a sound when the stimulus was delivered at frequencies equal to or above 400 Hz; were able to discriminate frequency differences between stimuli delivered at high stimulation frequencies (similar to 1500 Hz); improved their reaction time for bimodal stimuli (i.e. when both vibration and sound were perceived). Our results demonstrate that osseoperception is a multisensory perception, which can explain the improved environment perception of bone-anchored prosthesis users. This phenomenon might be exploited in novel prosthetic devices to enhance their control, thus ultimately improving the amputees' quality of life.
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| 2. |
- Fredén Jansson, Karl-Johan, 1988, et al.
(författare)
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Electro-acoustic performance of the new bone vibrator Radioear B81: A comparison with the conventional Radioear B71
- 2015
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Ingår i: International Journal of Audiology. - : Informa UK Limited. - 1499-2027 .- 1708-8186. ; 54:5, s. 334-340
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The objective is to evaluate the electro-acoustic performance of a new audiometric bone vibrator, the B81 from Radioear Corporation, USA. Comparison will be made with the widely used B71 which has well-known limitations at low frequencies. Design: The B81 is based on the balanced electromagnetic separation transducer (BEST) principle where static forces are counterbalanced so that nonlinear distortion forces are reduced and maximum hearing levels can be increased. Study sample: Maximum hearing level, total harmonic distortion (THD), frequency response, and electrical impedance were measured for six devices of each bone vibrator type on an artificial mastoid. Results: It was found that B81 reaches 10.7-22.0 dB higher maximum (@ THD. 6% or V-in. 6 V-RMS) hearing levels than B71 for frequencies below 1500 Hz, and had significantly lower THD up to 1000 Hz. There was no statistically significant difference between their frequency response, except a deviation at the mid frequencies (alpha = 0.01) where B81 was more efficient and the electrical impedances were practically the same. Conclusions: In general, B81 had an improved electro-acoustic performance compared to B71 and is compatible with same audiometers. In particular, B81 allows for sensorineural hearing loss to be measured at considerably higher hearing levels than with B71 below 1500 Hz.
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| 3. |
- 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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| 4. |
- 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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| 5. |
- Fredén Jansson, Karl-Johan, 1988, et al.
(författare)
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Vibrotactile Thresholds on the Mastoid and Forehead Position of Deaf Patients Using Radioear B71 and B81
- 2017
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Ingår i: Ear and Hearing. - 1538-4667 .- 0196-0202. ; 38:6, s. 714-723
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: The main objective of this study was to measure the vibrotactile thresholds on the mastoid process and forehead positions using patients with bilateral deafness and to compare the results from the two bone conduction vibrators Radioear B71 and B81. Design: There is a possibility that the vibrotactile sensation on the skin makes it difficult to discriminate between sound and vibration. The risk is highest for patients who have bone conduction hearing thresholds in proximity to or worse than their vibrotactile thresholds. All measurements were performed similar to regular bone conduction threshold testing using an audiometer-driven bone conduction vibrator and pulsed warble tones, but the patients were instructed to respond only when feeling vibrations of the bone conduction vibrator instead of when hearing sound. Both the posterior forehead position and the mastoid process position on the temporal bone were tested for comparative reasons. In total, 16 patients participated in the study, 31% females and 69% males of age 29 to 77 years. All subjects were cochlear implant recipients, either uni-or bilaterally implanted. They were selected based on their audiogram data showing unmeasurable unaided hearing. Results: The force level at which the vibrotactile thresholds were reached, increased with frequency from 125 up to 500 Hz, but remained constant for higher frequencies up to 2 kHz. A statistically significant difference was found between the 2 devices at 125 Hz at both the mastoid process and forehead position, where the vibrotactile threshold seem to be more sensitive for B71, possibly due to contribution of distortion components. There was no statistically significant difference in vibrotactile thresholds between the mastoid process and forehead position in absolute values (force level in dB re 1 mu N), but in terms of hearing levels (dB HL) there was an average difference of 10 and 9 dB for B71 and B81, respectively. Conclusions: The results indicate that the vibrotactile thresholds can be confounded with bone conduction hearing thresholds measurements up to 500 Hz when using a standard audiometer and in particular when measuring on the forehead position.
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| 6. |
- 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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| 7. |
- 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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| 8. |
- 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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| 9. |
- Reinfeldt, Sabine, 1978, et al.
(författare)
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The bone conduction implant: Clinical results of the first six patients.
- 2015
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Ingår i: International journal of audiology. - : Informa UK Limited. - 1708-8186 .- 1499-2027. ; 54:6, s. 408-416
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To investigate audiological and quality of life outcomes for a new active transcutaneous device, called the bone conduction implant (BCI), where the transducer is implanted under intact skin. Design: A clinical study with sound field audiometry and questionnaires at six-month follow-up was conducted with a bone-anchored hearing aid on a softband as reference device. Study sample: Six patients (age 18-67 years) with mild-to-moderate conductive or mixed hearing loss. Results: The surgical procedure was found uneventful with no adverse events. The first hypothesis that BCI had a statistically significant improvement over the unaided condition was proven by a pure-tone-average improvement of 31.0 dB, a speech recognition threshold improvement in quiet (27.0 dB), and a speech recognition score improvement in noise (51.2 %). At speech levels, the signal-to-noise ratio threshold for BCI was - 5.5 dB. All BCI results were better than, or similar to the reference device results, and the APHAB and GBI questionnaires scores showed statistically significant improvements versus the unaided situation, supporting the second and third hypotheses. Conclusions: The BCI provides significant hearing rehabilitation for patients with mild-to-moderate conductive or mixed hearing impairments, and can be easily and safely implanted under intact skin.
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| 10. |
- 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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