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1.
Int J Audiol ; : 1-7, 2024 May 14.
Artículo en Inglés | MEDLINE | ID: mdl-38742487

RESUMEN

OBJECTIVE: The objective is to evaluate the electroacoustic performance of the B250 transducer and to compare it with the two most widely used audiometric transducers B71 and B81. DESIGN: The electroacoustic performance was evaluated in terms of sensitivity level, distortion, maximum hearing level and electrical impedance. STUDY SAMPLE: Six B250 prototype transducers were evaluated and compared with published data of B71 and B81 together with complementary measurements of maximum hearing level at 125 Hz and phase of electrical impedance. Differences in reference equivalent threshold vibratory force levels were estimated by comparing hearing threshold measurements of 60 healthy ears using B81 and B250. RESULTS: B250 has approximately 27 dB higher sensitivity levels than both B71 and B81 at 250 Hz and can generate higher maximum hearing level at low frequencies: 11.8 to 35.8 dB (125-1000 Hz) higher than B71, and 1.4 to 18.6 dB (125-750 Hz) higher than B81. The maximum average difference in reference threshold force levels was 13.5 ± 8.7 dB higher for B250 at 250 Hz compared to B81. CONCLUSIONS: B250 can produce higher output force with less distortion than B71 and B81, especially at 125 and 250 Hz, which could possibly improve low frequency investigations of the audio-vestibular system.

2.
Int J Audiol ; : 1-7, 2024 Apr 11.
Artículo en Inglés | MEDLINE | ID: mdl-38602203

RESUMEN

OBJECTIVE: To objectively measure audibility in patients wearing bone conduction devices (BCDs) with a new approach using a skin microphone at the patient's forehead. DESIGN: The skin microphone was attached by a softband and shielded by an earmuff. This set-up was confirmed not to be influenced by neither noise floor nor sound bypassing the BCD. Sound field warble tones were used for measuring aided hearing thresholds and maximum power output (MPO) whereas an international speech test signal (ISTS) was presented at different speech levels. STUDY SAMPLE: 29 patients were tested (two were bilateral), 19 used percutaneous, eight used active transcutaneous and two used passive transcutaneous devices. RESULTS: The skin microphone responses at ISTS levels, hearing threshold and MPO, could be obtained in all patients. Two patients with poor audibility are highlighted in this article as examples. After adjusting the gain of the BCD, they were retested with the skin microphone (for verification) and with speech-in-noise tests (for validation). Both tests confirmed an improved audibility after the adjustments. CONCLUSION: In summary, the proposed measurement of audibility of speech using a skin microphone is a promising method that can be used in a clinical setting for all types of BCDs.

3.
Otol Neurotol ; 44(10): e739-e746, 2023 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-37832576

RESUMEN

INTRODUCTION: A simultaneous recording of cervical and ocular vestibular evoked myogenic potential (sVEMP) to unilateral air-conducted (AC) stimulation reduces the test time and halves the sound load. MATERIALS AND METHODS: The sVEMP has been compared with the conventional sequential unilateral AC cervical and ocular VEMP in a consecutive cohort of 120 subjects attending the vestibular laboratory. The stimulus was a 500-Hz 6-ms tone burst, at 130 dB peSPL for sequential recordings but at 125 dB for the added sVEMP, for cumulative sound load containment. Amplitudes, latencies, and amplitude asymmetry ratios (ARs) were the parameters included in analysis. RESULTS: Relevant results were as follows: 1) significantly lower amplitudes in sVEMP versus VEMP (ocular recordings, median = 2.90 [IQR = 0-4.98] vs. 4.15 [1.73-8.98] µV, p < 0.001; cervical, 0.84 [0.30-1.69] vs. 1.36 [0.60-2.30], p < 0.001; electromyography scaled values); 2) 10% lower response rate at cervical recordings and 11% at ocular recordings in sVEMP, particularly in older subjects; 3) significant correlations between cervical amplitudes ( rs = 0.88, p < 0.001), ocular amplitudes ( rs = 0.71, p < 0.001), peak latencies ( rs = 0.36-0.67, p < 0.001), and ARs (ocular, rs = 0.56; cervical, rs = 68, p < 0.001); and 4) good agreement in pathological AR detection (cervical recordings, Cohen's κ = 0.649, p < 0.001; ocular, κ = 0.589, p < 0.001). DISCUSSION: AC sVEMP showed good correlation/agreement with sequential AC VEMP. Test time containment and halved sound load are clinical adds in sVEMP, opening to its use as laboratory standard. However, AC sVEMP presented reduced amplitudes and response rates, secondary to the reduced AC stimulation used in this study to allow checking of the null responses and the pathological ARs at AC sVEMP with conventional AC VEMP.


Asunto(s)
Ojo , Potenciales Vestibulares Miogénicos Evocados , Humanos , Anciano , Estimulación Acústica/métodos , Potenciales Vestibulares Miogénicos Evocados/fisiología , Sonido , Electromiografía
4.
Audiol Neurootol ; 28(3): 219-229, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36634643

RESUMEN

INTRODUCTION: The aim of this study was to develop a clinical test for body sounds' hypersensitivity in superior canal dehiscence syndrome (SCDS). METHOD: Case-control study, 20 patients affected by SCDS and body sounds' hypersensitivity and 20 control matched subjects tested with a new test called ankle audiometry (AA). The AA consisted of a psychoacoustic hearing test in which the stimulus was substituted by a controlled bone vibration at 125, 250, 500, and 750 Hz, delivered at the medial malleolus by a steel spring-attached bone transducer prototype B250. For each subject, it was defined an index side (the other being non-index), the one with major symptoms in cases or best threshold for each tested frequency in controls. In 3 patients, the AA was measured before and after SCDS surgery. RESULTS: The AA thresholds for index side were significantly lower in SCDS patients (115.6 ± 10.5 dB force level [FL]) than in control subjects (126.4 ± 8.56 dB FL). In particular, the largest difference was observed at 250 Hz (-16.5 dB). AA thresholds in patients were significantly lower at index side in comparison with non-index side (124.2 ± 11.4 dB FL). The response obtained with 250 Hz stimuli outperformed the other frequencies, in terms of diagnostic accuracy for SCDS. At specific thresholds' levels (120 dB FL), AA showed relevant sensitivity (90%) and specificity (80%) for SCDS. AA did not significantly correlate to other clinical markers of SCDS such as the bone and air conducted hearing thresholds and the vestibular evoked myogenic potentials. The AA thresholds were significantly modified by surgical intervention, passing from 119.2 ± 9.7 to 130.4 ± 9.4 dB FL in 3 patients, following their relief in body sounds' hypersensitivity. CONCLUSION: AA showed interesting diagnostic features in SCDS with significantly lower hearing thresholds in SCDS patients when compared to healthy matched subjects. Moreover, AA could identify the affected or more affected side in SCDS patients, with a significant threshold elevation after SCDS surgery, corresponding in body sounds' hypersensitivity relief. Clinically, AA may represent a first objective measure of body sounds' hypersensitivity in SCDS and, accordingly, be an accessible screening test for SCDS in not tertiary audiological centers.


Asunto(s)
Dehiscencia del Canal Semicircular , Potenciales Vestibulares Miogénicos Evocados , Humanos , Estudios de Casos y Controles , Tobillo , Canales Semicirculares/cirugía , Audiometría , Potenciales Vestibulares Miogénicos Evocados/fisiología , Audición
5.
Int J Audiol ; 62(4): 357-361, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-35238713

RESUMEN

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.


Asunto(s)
Audífonos , Humanos , Conducción Ósea/fisiología , Proyectos Piloto , Audición , Pérdida Auditiva Conductiva/diagnóstico , Pérdida Auditiva Conductiva/rehabilitación
7.
Hear Res ; 421: 108503, 2022 08.
Artículo en Inglés | MEDLINE | ID: mdl-35490057

RESUMEN

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 measurements 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 conductive and mild-to-moderate mixed hearing loss.


Asunto(s)
Audífonos , Perdida Auditiva Conductiva-Sensorineural Mixta , Pérdida Auditiva , Percepción del Habla , Audiometría , Conducción Ósea/fisiología , Estudios de Seguimiento , Pérdida Auditiva Conductiva , Perdida Auditiva Conductiva-Sensorineural Mixta/diagnóstico , Perdida Auditiva Conductiva-Sensorineural Mixta/terapia , Humanos , Resultado del Tratamiento
9.
Med Devices (Auckl) ; 14: 225-237, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34267559

RESUMEN

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.

10.
Commun Med (Lond) ; 1: 37, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-35602216

RESUMEN

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.

11.
Med Devices (Auckl) ; 13: 293-313, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33061679

RESUMEN

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.

12.
Sci Rep ; 10(1): 11793, 2020 07 16.
Artículo en Inglés | MEDLINE | ID: mdl-32678121

RESUMEN

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.


Asunto(s)
Retroalimentación Fisiológica , Fuerza de la Mano , Prótesis e Implantes , Desempeño Psicomotor , Miembros Artificiales , Retroalimentación Sensorial , Humanos , Actividad Motora , Enfermedades Neuromusculares/rehabilitación , Enfermedades Neuromusculares/cirugía , Investigación Cualitativa
13.
Audiol Neurootol ; 25(5): 263-275, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32268333

RESUMEN

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.


Asunto(s)
Conducción Ósea , Audífonos , Pérdida Auditiva Conductiva/rehabilitación , Perdida Auditiva Conductiva-Sensorineural Mixta/rehabilitación , Audición/fisiología , Calidad de Vida , Percepción del Habla/fisiología , Adolescente , Adulto , Anciano , Audiometría , Femenino , Estudios de Seguimiento , Pérdida Auditiva Conductiva/fisiopatología , Perdida Auditiva Conductiva-Sensorineural Mixta/fisiopatología , Pruebas Auditivas , Humanos , Masculino , Persona de Mediana Edad , Encuestas y Cuestionarios , Adulto Joven
14.
Int J Audiol ; 58(12): 945-955, 2019 12.
Artículo en Inglés | MEDLINE | ID: mdl-31710259

RESUMEN

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.


Asunto(s)
Conducción Ósea , Audífonos , Pérdida Auditiva Conductiva/cirugía , Implantación de Prótesis/métodos , Adolescente , Adulto , Anciano , Femenino , Estudios de Seguimiento , Pérdida Auditiva Conductiva/rehabilitación , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Adulto Joven
15.
Hear Res ; 381: 107763, 2019 09 15.
Artículo en Inglés | MEDLINE | ID: mdl-31387072

RESUMEN

Direct drive bone conduction devices (BCDs) are used to rehabilitate patients with conductive or mixed hearing loss by stimulating the skull bone directly, either with an implanted transducer (active transcutaneous BCDs), or through a skin penetrating abutment rigidly coupled to an external vibrating transducer (percutaneous BCDs). Active transcutaneous BCDs have been under development to overcome limitations of the percutaneous bone anchored hearing aid (BAHA), mainly related to the skin penetration. The attachment of a direct drive BCD to the skull bone can differ significantly between devices, and possibly influence the vibrations' transmission to the cochleae. In this study, four different attachments are considered: (A) small-sized flat surface, (B) extended flat surface, (C) bar with a screw at both ends, and (D) standard bone anchored hearing aid screw. A, B, and C represent three active transcutaneous options, while D is for percutaneous applications. The primary aim of this study was to investigate how the different transcutaneous attachments (A, B, and C) affect the transmission of vibrations to the cochleae to the ipsilateral and the contralateral side. A secondary aim was to evaluate and compare transcranial attenuation (TA, ipsilateral minus contralateral signal level) between transcutaneous (A, B, and C) and percutaneous attachments (D). Measurements were performed on four human heads, measuring cochlear promontory velocity with a LDV (laser Doppler vibrometer) and sound pressure in the ear canal (ECSP) with an inserted microphone. The stimulation signal was a swept sine between 0.1 and 10 kHz. The comparison of ipsilateral transmission between transcutaneous adaptors A, B, and C was in agreement with previous findings, confirming that: (1) Adaptor C seems to give the most effective transmission for frequencies around 6 kHz but somewhat lower in the mid frequency range, and (2) keeping a smaller contact area seems to provide advantages compared to a more extended one. The same trends were seen ipsilaterally and contralaterally. The observed TA was similar for adaptors A, B, and C at the mastoid position, ranging -10-0 dB below 500 Hz, and 10-20 dB above. A lower TA was seen above 500 Hz when using adaptor D at the parietal position.


Asunto(s)
Conducción Ósea , Prótesis Anclada al Hueso , Cóclea/fisiopatología , Audífonos , Pérdida Auditiva/rehabilitación , Apófisis Mastoides/cirugía , Hueso Parietal/cirugía , Personas con Deficiencia Auditiva/rehabilitación , Implantación de Prótesis/instrumentación , Cadáver , Femenino , Pérdida Auditiva/fisiopatología , Humanos , Masculino , Mecanotransducción Celular , Diseño de Prótesis , Vibración
16.
Med Devices (Auckl) ; 12: 193-202, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31239790

RESUMEN

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.

17.
J Neuroeng Rehabil ; 16(1): 49, 2019 04 11.
Artículo en Inglés | MEDLINE | ID: mdl-30975158

RESUMEN

BACKGROUND: Replacement of a lost limb by an artificial substitute is not yet ideal. Resolution and coordination of motor control approximating that of a biological limb could dramatically improve the functionality of prosthetic devices, and thus reduce the gap towards a suitable limb replacement. METHODS: In this study, we investigated the control resolution and coordination exhibited by subjects with transhumeral amputation who were implanted with epimysial electrodes and an osseointegrated interface that provides bidirectional communication in addition to skeletal attachment (e-OPRA Implant System). We assessed control resolution and coordination in the context of routine and delicate grasping using the Pick and Lift and the Virtual Eggs Tests. Performance when utilizing implanted electrodes was compared with the standard-of-care technology for myoelectric prostheses, namely surface electrodes. RESULTS: Results showed that implanted electrodes provide superior controllability over the prosthetic terminal device compared to conventional surface electrodes. Significant improvements were found in the control of the grip force and its reliability during object transfer. However, these improvements failed to increase motor coordination, and surprisingly decreased the temporal correlation between grip and load forces observed with surface electrodes. We found that despite being more functional and reliable, prosthetic control via implanted electrodes still depended highly on visual feedback. CONCLUSIONS: Our findings indicate that incidental sensory feedback (visual, auditory, and osseoperceptive in this case) is insufficient for restoring natural grasp behavior in amputees, and support the idea that supplemental tactile sensory feedback is needed to learn and maintain the motor tasks internal model, which could ultimately restore natural grasp behavior in subjects using prosthetic hands.


Asunto(s)
Miembros Artificiales , Electrodos Implantados , Desempeño Psicomotor/fisiología , Amputados , Electromiografía/instrumentación , Electromiografía/métodos , Retroalimentación Sensorial , Femenino , Fuerza de la Mano , Humanos , Masculino , Reproducibilidad de los Resultados
18.
Med Devices (Auckl) ; 12: 89-100, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-30881150

RESUMEN

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.

19.
Med Devices (Auckl) ; 11: 301-312, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-30233258

RESUMEN

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.

20.
IEEE J Transl Eng Health Med ; 6: 2600112, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29637030

RESUMEN

The functionality of upper limb prostheses can be improved by intuitive control strategies that use bioelectric signals measured at the stump level. One such strategy is the decoding of motor volition via myoelectric pattern recognition (MPR), which has shown promising results in controlled environments and more recently in clinical practice. Moreover, not much has been reported about daily life implementation and real-time accuracy of these decoding algorithms. This paper introduces an alternative approach in which MPR allows intuitive control of four different grips and open/close in a multifunctional prosthetic hand. We conducted a clinical proof-of-concept in activities of daily life by constructing a self-contained, MPR-controlled, transradial prosthetic system provided with a novel user interface meant to log errors during real-time operation. The system was used for five days by a unilateral dysmelia subject whose hand had never developed, and who nevertheless learned to generate patterns of myoelectric activity, reported as intuitive, for multi-functional prosthetic control. The subject was instructed to manually log errors when they occurred via the user interface mounted on the prosthesis. This allowed the collection of information about prosthesis usage and real-time classification accuracy. The assessment of capacity for myoelectric control test was used to compare the proposed approach to the conventional prosthetic control approach, direct control. Regarding the MPR approach, the subject reported a more intuitive control when selecting the different grips, but also a higher uncertainty during proportional continuous movements. This paper represents an alternative to the conventional use of MPR, and this alternative may be particularly suitable for a certain type of amputee patients. Moreover, it represents a further validation of MPR with dysmelia cases.

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