| 1. |
- Fredén Jansson, Karl-Johan, 1988, et al.
(författare)
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Bone Conduction Stimulated VEMP Using the B250 Transducer
- 2021
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Ingår i: Medical Devices: Evidence and Research. - 1179-1470. ; 14, s. 225-237
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Bone conduction (BC) stimulation is rarely used for clinical testing of vestibular evoked myogenic potentials (VEMPs) due to the limitations of conventional stimulation alternatives. The aim of this study is to compare VEMP using the new B250 transducer with the Minishaker and air conduction (AC) stimulation. Methods: Thirty normal subjects between 20 and 37 years old and equal gender distribution were recruited, 15 for ocular VEMP and 15 for cervical VEMP. Four stimulation conditions were compared: B250 on the mastoid (FM); Minishaker and B250 on the forehead (FZ); and AC stimulation using an insert earphone. Results: It was found that B250 at FM required a statistically significant lower hearing level than with AC stimulation, in average 41 dB and 35 dB lower for ocular VEMP and cervical VEMP, respectively, but gave longer n10 (1.1 ms) and n23 (1.6 ms). No statistical difference was found between B250 at FM and Minishaker at FZ. Conclusion: VEMP stimulated with B250 at FM gave similar response as the Minishaker at FZ and for a much lower hearing level than AC stimulation using insert earphones.
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| 2. |
- Håkansson, Bo, 1953, et al.
(författare)
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The mechanical impedance of the human skull via direct bone conduction implants
- 2020
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Ingår i: Medical Devices: Evidence and Research. - 1179-1470. ; 13, s. 293-313
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: The mechanical skull impedance is used in the design of direct bone drive hearing systems. This impedance is also important for the design of skull simulators used in manufacturing, service, and fitting procedures of such devices. Patients and Methods: The skull impedance was measured in 45 patients (25 female and 20 male) who were using percutaneous bone conduction implants (Ponto system or Baha system). Patients were recruited as a consecutive prospective case series and having an average age of 55.4 years (range 18–80 years). Seven patients were treated in Gothenburg, Sweden, and 38 patients in Edmonton, Canada. An impedance head (B&K 8001), driven by an excitation transducer with emphasized low-frequency response, was used to measure the mechanical point impedance with a swept sine from 100 to 10k Hz. Results and Discussion: The skull impedance was found to have an anti-resonance of approximately 150 Hz, with a median maximum magnitude of 4500 mechanical ohms. Below this anti-resonance, the mechanical impedance was mainly mass-controlled corresponding to an effective skull mass of 2.5 kg at 100 Hz with substantial damping from neck and shoulder. Above the anti-resonance and up to 4 kHz, the impedance was stiffness-controlled, with a total compliance of approximately 450n m/N with a small amount of damping. At frequencies above 4 kHz, the skull impedance becomes gradually mass-controlled originating from the mass of the osseointegrated implant and adjacent bone. No significant differences related to gender or skull abnormalities were seen, just a slight dependence on age and major ear surgeries. The variability of the mechanical impedance among patients was not found to have any clinical importance. Conclusion: The mechanical skull impedance of percutaneous implants was found to confirm previous studies and can be used for optimizing the design and test procedures of direct bone drive hearing implants. © 2020 Håkansson et al.
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| 3. |
- Maier, Hannes, et al.
(författare)
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Consensus Statement on Bone Conduction Devices and Active Middle Ear Implants in Conductive and Mixed Hearing Loss
- 2022
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Ingår i: Otology and Neurotology. - : Lippincott, Williams & Wilkins. - 1531-7129 .- 1537-4505. ; 43:5, s. 513-529
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Tidskriftsartikel (refereegranskat)abstract
- Nowadays, several options are available to treat patients with conductive or mixed hearing loss. Whenever surgical intervention is not possible or contra-indicated, and amplification by a conventional hearing device (e.g., behind-the-ear device) is not feasible, then implantable hearing devices are an indispensable next option. Implantable bone-conduction devices and middle-ear implants have advantages but also limitations concerning complexity/invasiveness of the surgery, medical complications, and effectiveness. To counsel the patient, the clinician should have a good overview of the options with regard to safety and reliability as well as unequivocal technical performance data. The present consensus document is the outcome of an extensive iterative process including ENT specialists, audiologists, health-policy scientists, and representatives/technicians of the main companies in this field. This document should provide a first framework for procedures and technical characterization to enhance effective communication between these stakeholders, improving health care.
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| 4. |
- Mastinu, Enzo, 1987, et al.
(författare)
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Neural feedback strategies to improve grasping coordination in neuromusculoskeletal prostheses
- 2020
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Ingår i: Scientific Reports. - : Springer Science and Business Media LLC. - 2045-2322 .- 2045-2322. ; 10:1
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Tidskriftsartikel (refereegranskat)abstract
- Conventional prosthetic arms suffer from poor controllability and lack of sensory feedback. Owing to the absence of tactile sensory information, prosthetic users must rely on incidental visual and auditory cues. In this study, we investigated the effect of providing tactile perception on motor coordination during routine grasping and grasping under uncertainty. Three transhumeral amputees were implanted with an osseointegrated percutaneous implant system for direct skeletal attachment and bidirectional communication with implanted neuromuscular electrodes. This neuromusculoskeletal prosthesis is a novel concept of artificial limb replacement that allows to extract control signals from electrodes implanted on viable muscle tissue, and to stimulate severed afferent nerve fibers to provide somatosensory feedback. Subjects received tactile feedback using three biologically inspired stimulation paradigms while performing a pick and lift test. The grasped object was instrumented to record grasping and lifting forces and its weight was either constant or unexpectedly changed in between trials. The results were also compared to the no-feedback control condition. Our findings confirm, in line with the neuroscientific literature, that somatosensory feedback is necessary for motor coordination during grasping. Our results also indicate that feedback is more relevant under uncertainty, and its effectiveness can be influenced by the selected neuromodulation paradigm and arguably also the prior experience of the prosthesis user.
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| 5. |
- Persson, Ann-Charlotte, 1970, et al.
(författare)
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A novel method for objective in-situ measurement of audibility in bone conduction hearing devices - a pilot study using a skin drive BCD
- 2023
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Ingår i: International Journal of Audiology. - : Informa UK Limited. - 1499-2027 .- 1708-8186. ; 62:4, s. 357-361
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Tidskriftsartikel (refereegranskat)abstract
- Objective Objective measurement of audibility (verification) using bone conduction devices (BCDs) has long remained an elusive problem for BCDs. For air conduction hearing aids there are well-defined and often used objective methods, and the aim of this study is to develop an objective method for BCDs. Design In a novel setup for audibility measurements of bone-anchored hearing aid (BAHA) attached via a soft band, we used a skin microphone (SM) on the forehead measuring in-situ sound field thresholds, maximum power output (MPO) and international speech test signal (ISTS) responses. Study sample Five normal-hearing persons. Result Using the electrical output of SM it was possible to objectively measure the audibility of a skin drive BCD, presented as an eSPL-o-gram showing thresholds, MPO and ISTS response. Normalised eSPL-o-gram was verified against corresponding FL-o-grams (corresponding force levels from skull simulator and artificial mastoid (AM)). Conclusion The proposed method with the SM can be used for objective measurements of the audibility of any BCDs based on thresholds, MPO and speech response allowing for direct comparisons of hearing and BCD output on the same graph using an eSPL-o-gram. After normalisation to hearing thresholds, the audibility can be assessed without the need for complicated calibration procedures.
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| 6. |
- 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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| 7. |
- Plontke, Stefan K., et al.
(författare)
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A case series shows independent vestibular labyrinthine function after major surgical trauma to the human cochlea
- 2021
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Ingår i: Communications Medicine. - : Springer Science and Business Media LLC. - 2730-664X. ; 1:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: The receptors for hearing and balance are housed together in the labyrinth of the inner ear and share the same fluids. Surgical damage to either receptor system was widely believed to cause certain permanent loss of the receptor function of the other. That principle, however, has been called into question because there have been anecdotal reports in individual patients of at least partial preservation of cochlear function after major surgical damage to the vestibular division and vice versa. Methods: We performed specific objective vestibular function tests before and after surgical trauma (partial or subtotal cochlear removal) for treatment of intracochlear tumors in 27 consecutive patients in a tertiary referral center. Vestibular function was assessed by calorics (low-frequency response of the lateral semicircular canal), vestibulo-ocular reflex by video head impulse test (vHIT) of the three semicircular canals, cervical and ocular vestibular evoked myogenic potentials (cVEMP, saccule and oVEMP, utricle). Preoperative and postoperative distributions were compared with paired t-tests. Results: Here we show that there was no significant difference between pre- and post-operative measures for all tests of the five vestibular organs, and that after major surgical cochlear trauma, the vestibular receptors continue to function independently. Conclusions: These surprising observations have important implications for our understanding of the function and the surgery of the peripheral auditory and vestibular system in general and open up new possibilities for the development, construction and evaluation of neural interfaces for electrical or optical stimulation of the peripheral auditory and vestibular nervous system.
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| 8. |
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| 9. |
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| 10. |
- Reinfeldt, Sabine, 1978, et al.
(författare)
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Long-term follow-up and review of the Bone Conduction Implant
- 2022
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Ingår i: Hearing Research. - : Elsevier BV. - 0378-5955 .- 1878-5891. ; 421
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Tidskriftsartikel (refereegranskat)abstract
- Active transcutaneous bone conduction devices are a type of bone conduction device developed to keep the skin intact and provide direct bone conduction stimulation. The Bone Conduction Implant (BCI) is such a device and has been implanted in 16 patients. The objective of this paper is to give a broad overview of the BCI development to the final results of 13 patients at 5-year follow-up. Follow-up of these patients included audiological performance investigations, questionnaires, as well as safety evaluation and objective functionality testing of the device. Among those audiological measure-ments were sound field warble tone thresholds, speech recognition threshold (SRT), speech recognition score (SRS) and signal to noise ratio threshold (SNR-threshold).The accumulated implant time for all 16 patients was 113 years in February 2022. During this time, no serious adverse events have occurred. The functional improvement for the 13 patients reported in this paper was on average 29.5 dB (average over 0.5, 1, 2 and 4 kHz), while the corresponding effective gain was-12.4 dB. The SRT improvement was 24.5 dB and the SRS improvement was 38.1%, while the aided SNR-threshold was on average -6.4 dB.It was found that the BCI can give effective and safe hearing rehabilitation for patients with conduc-tive and mild-to-moderate mixed hearing loss. (c) 2022 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY license ( http://creativecommons.org/licenses/by/4.0/ )
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