OBJECTIVE: To address the clinical need for totally implantable mechanical circulatory support devices, Bionet Sonar is developing a novel Ultrasonic Transcutaneous Energy Transmission (UTET) system that is designed to eliminate external power and/or data communication drivelines.
METHODS: UTET systems were designed, fabricated, and pre-clinically tested using a non-clinical HeartWare HVAD in static and dynamic mock flow loop and acute animal models over a range of pump speeds (1800, 2400, 3000 RPM) and tissue analogue thicknesses (5, 10, 15 mm).
RESULTS: The prototypes demonstrated feasibility as evidenced by meeting/exceeding function, operation, and performance metrics with no system failures, including achieving receiver (harvested) power exceeding HVAD power requirements and data communication rates of 10kB/s and pump speed control (> 95% sensitivity and specificity) for all experimental test conditions, and within healthy tissue temperature range with no acute tissue damage.
CONCLUSIONS: During early-stage development and testing, engineering challenges for UTET size reduction and stable and safe operation were identified, with solutions and plans to address the limitations in future design iterations also presented.

One aspect of reproducibility in preclinical research that is frequently overlooked is the physical condition in which physiological, pharmacological, or behavioural recordings are conducted. In this study, the physical conditions of mice were altered through the attachments of wireless electrophysiological recording devices (Neural Activity Tracker-1, NAT-1). NAT-1 devices are miniaturised multichannel devices with onboard memory for direct high-resolution recording of brain activity for >48 h. Such devices may limit the mobility of animals and affect their behavioural performance due to the added weight (total weight of approximately 3.4 g). The mice were additionally treated with saline (control), N-methyl-D-aspartate (NMDA) receptor antagonist MK801 (0.85 mg/kg), or the muscarinic acetylcholine receptor blocker scopolamine (0.65 mg/kg) to allow exploration of the effect of NAT-1 attachments in pharmacologically treated mice. We found only minimal differences in behavioural outcomes with NAT-1 attachments in standard parameters of locomotor activity widely reported for the open field test between the drug treatments. Hypoactivity was globally observed as a consistent outcome in the MK801-treated mice and hyperactivity in scopolamine groups regardless of NAT-1 attachments. These data collectively confirm the reproducibility for combined behavioural, pharmacological, and physiological endpoints even in the presence of lightweight wireless data loggers. The NAT-1 therefore constitutes a pertinent tool for investigating brain activity in, e.g., drug discovery and models of neuropsychiatric and/or neurodegenerative diseases with minimal effects on pharmacological and behavioural outcomes.

OBJECTIVE: To report the accuracy and reliability of Cobb angle (CA), axial vertebral rotation (AVR), kyphotic and lordotic angles (KA and LA) measurements on using a new 3D ultrasound (US) system.
METHODS: Forty participants (34 F, 6 M, aged 14.0 ± 2.3 years) were recruited. The first 20 participants were scanned by the validated US system and the new US system. The other 20 participants were scanned with the new US system only. Two raters (R1 and R2) performed the measurements: R1 has 10 years of experience in radiology but is new in ultrasound scoliosis, while R2 has 30 years of scoliosis experience. All US images were measured twice by R1, and once by R2. Forty posteroanterior and 30 lateral standing radiographs were obtained and measured once by R1. Statistical analysis consisted of mean absolute difference (MAD), intraclass correlation coefficient (ICC (2,1)), and Bland-Altman plots.
RESULTS: R1 showed excellent intra-rater and inter-rater reliability for US measurements with ICCs(2,1) ≥ 0.91. The inter-method reliability was good between the two US systems for all parameters with ICCs(2,1) ≥ 0.85 and maximum MAD of 3.4°. The new US showed good reliability and accuracy compared to radiographs for CA, AVR and KA with ICCs(2,1) ≥ 0.81 and maximum MAD of 5.8°, but poor results for LA with ICCs(2,1) of 0.27-0.35 and MADs of 14.0°-15.4°.
CONCLUSIONS: The new 3D US system showed good reliability and accuracy for CA, AVR and KA measurements, but a large measurement discrepancy on LA. A new measurement method for US LA may need to investigate.

UNASSIGNED: Better interoperability is essential to derive maximum benefit from connected wireless diabetes devices. The need for this feature of diabetes devices is supported by trends in designing better performance for three types of devices: nonmedical devices, medical devices, and diabetes devices.
UNASSIGNED: First, interoperability is a standard attribute for the performance of nonmedical devices contained in smart systems that can sense and actuate. Second, interoperability is now mandated by the US Department of Health and Human Services as carried out by the Office of the National Coordinator for Health Information technology (ONC) and the US Food and Drug Administration (FDA) to improve the performance of all medical devices. Third, new guidance from the FDA and nongovernmental professional organizations are intended to promote interoperability because this feature will improve the performance of all diabetes devices.
UNASSIGNED: Wireless devices perform best when they are interoperable, and this is particularly true for diabetes devices.

The discovery and development of electrocochleography (ECochG) in animal models has been fundamental for its implementation in clinical audiology and neurotology. In our laboratory, the use of round-window ECochG recordings in chinchillas has allowed a better understanding of auditory efferent functioning. In previous works, we gave evidence of the corticofugal modulation of auditory-nerve and cochlear responses during visual attention and working memory. However, whether these cognitive top-down mechanisms to the most peripheral structures of the auditory pathway are also active during audiovisual crossmodal stimulation is unknown. Here, we introduce a new technique, wireless ECochG to record compound-action potentials of the auditory nerve (CAP), cochlear microphonics (CM), and round-window noise (RWN) in awake chinchillas during a paradigm of crossmodal (visual and auditory) stimulation. We compared ECochG data obtained from four awake chinchillas recorded with a wireless ECochG system with wired ECochG recordings from six anesthetized animals. Although ECochG experiments with the wireless system had a lower signal-to-noise ratio than wired recordings, their quality was sufficient to compare ECochG potentials in awake crossmodal conditions. We found non-significant differences in CAP and CM amplitudes in response to audiovisual stimulation compared to auditory stimulation alone (clicks and tones). On the other hand, spontaneous auditory-nerve activity (RWN) was modulated by visual crossmodal stimulation, suggesting that visual crossmodal simulation can modulate spontaneous but not evoked auditory-nerve activity. However, given the limited sample of 10 animals (4 wireless and 6 wired), these results should be interpreted cautiously. Future experiments are required to substantiate these conclusions. In addition, we introduce the use of wireless ECochG in animal models as a useful tool for translational research.

OBJECTIVE: The purpose of this study was to evaluate the efficacy of auditory training (AT) in patients with unilateral hearing loss (UHL) using hearing aids (HAs), comparing traditional methods with a new approach involving a wireless remote microphone.
METHODS: The study included 96 participants, divided into two groups, with ages ranging from 42 to 64 years, comprising both male and female subjects. A clinical trial including consecutive moderate UHL patients was performed at our institution. For the study group, a Roger Pen was used during AT with patients inside a sound-attenuating cabin. Controls followed conventional sessions. Professional speech and language pathologists performed the rehabilitation. Audiological outcomes were measured, including word recognition at signal-to-noise ratios (SNRs) of 0 dB, +5 dB, and +10 dB, to determine the effectiveness of the training. Measurements also included the Speech, Spatial, and Qualities of Hearing Scale to assess perceived auditory abilities.
RESULTS: A total of 46 and 50 UHL patients were randomly included in the study and control groups, respectively. No differences were found in terms of sex, age, presence of tinnitus, duration of hearing loss, pure tone average, and speech-in-noise perception without an HA. Following HA fitting and AT, a notable enhancement in the ability to identify speech in noisy environments was observed in the study group. This improvement was significant at SNRs of +5 and +10. When comparing the ability to identify speech in noise using HAs across both groups, it was observed that hearing capabilities post-wireless AT showed a significant improvement at an SNR of +5. Only the study group had a significant improvement in the total Speech, Spatial, and Qualities of Hearing Scale score after the training.
CONCLUSIONS: In our group of UHL patients, we found significantly better speech-in-noise perception when HA fitting was followed by wireless AT. Wireless AT may facilitate usage of HAs, leading to binaural hearing in UHL patients. Our findings suggest that future interventions might benefit from incorporating wireless technology in AT programs.

Electromagnetic fields create potential negative implications on biological systems, including modifications to DNA structure, nuclear condensation, cellular ion transport, and intracellular Ca2+ accumulation. To explore these effects on cancer cells, we exposed prostate, glioblastoma and cervix cancer cell lines to electromagnetic fields of wireless and assessed its anti-proliferative effects. PC3, A172, and HeLa cancer cells were cultured and exposed to electromagnetic fields for 24, 48, and 72 h. We used the MTT assay to detect cell viability and proliferation, Annexin V staining to determine apoptotic cells, and confocal microscopy to measure apoptosis-mediated intracellular calcium signals. Additionally, we performed profiling for apoptosis-related miRNAs. The results indicated that the electromagnetic field triggers apoptosis in the glioblastoma cell line A172 by increasing level of miR-129-5p, a known tumor suppressor. In contrast, the cervix cancer cell line and the prostate cancer cell line remained largely unaffected. In summary, our investigation underscores that electromagnetic fields at a 2.4 GHz frequency may adversely affect certain cancer cell lines, notably triggering apoptosis in the glioblastoma cancer cell line.

Continuous monitoring of physiological signals from the human body is critical in health monitoring, disease diagnosis, and therapeutics. Despite the needs, the existing wearable medical devices rely on either bulky wired systems or battery-powered devices needing frequent recharging. Here, we introduce a wearable, self-powered, thermoelectric flexible system architecture for wireless portable monitoring of physiological signals without recharging batteries. This system harvests an exceptionally high open circuit voltage of 175-180 mV from the human body, powering the wireless wearable bioelectronics to detect electrophysiological signals on the skin continuously. The thermoelectric system shows long-term stability in performance for 7 days with stable power management. Integrating screen printing, laser micromachining, and soft packaging technologies enables a multilayered, soft, wearable device to be mounted on any body part. The demonstration of the self-sustainable wearable system for detecting electromyograms and electrocardiograms captures the potential of the platform technology to offer various opportunities for continuous monitoring of biosignals, remote health monitoring, and automated disease diagnosis.

OBJECTIVE: To develop and evaluate a photovoltaic, wireless wide-field epiretinal prosthesis for the treatment of retinitis pigmentosa.
METHODS: A mosaic array of thinned silicon-based photodiodes with integrated thin-film stimulation electrodes was fabricated with a flexible polyimide substrate film to form a film-based miniaturized electronic system with wireless optical power and signal transmission and integrated electrostimulation. Manufactured implants were characterized with respect to their optoelectronic performance and biocompatibility following DIN EN ISO 10993.
RESULTS: A 14 mm diameter prosthesis containing 1276 pixels with a maximum sensitivity at a near infrared wavelength of 905 nm and maximized stimulation current density 30-50 μm below the electrodes was developed for direct activation of retinal ganglion cells during epiretinal stimulation. Fabricated prostheses demonstrated mucosal tolerance and the preservation of both metabolic activity, proliferation and membrane integrity of human fibroblasts as well as the retinal functions of bovine retinas. Illumination of the prosthesis, which was placed epiretinally on an isolated perfused bovine retina, with infrared light resulted in electrophysiological recordings reminiscent of an a-wave (hyperpolarization) and b-wave (depolarization).
CONCLUSIONS: A photovoltaic, wireless wide-field epiretinal prosthesis for the treatment of retinitis pigmentosa using near infrared light for signal transmission was designed, manufactured and its biocompatibility and functionality demonstrated in vitro and ex vivo.

With the continuous development of wearable electronics, higher requirements are put forward for flexible, detachable, stable output, and long service life power modules. Given the limited capacity of energy storage devices, the integration of energy capture and storage is a viable approach. Here, we present a flexible, wearable, wireless-charging power system that integrates a piezoelectric ultrasonic array harvester (PUAH) with MXene-based solid-state supercapacitors (MSSSs) in a soft wristband format for sustainable applications. The MSSS as the energy storage module is developed by using Ti3C2Tx nanosheet-loaded inserted finger-like carbon cloth skeletons as electrodes and poly(vinyl alcohol)/H3PO4 gel as electrolytes, with high energy density (58.74 Wh kg-1) and long cycle life (99.37%, 10,000 cycles). A two-dimensional stretchable piezoelectric array as a wireless-charging module hybridizes high-performance 1-3 composite units with serpentine electrodes, which allows wireless power via ultrasonic waves, with a maximum power density of 1.56 W cm-2 and an output voltage of 20.75 V. The overall PUAH-MSSS wireless energy supply system is 2 mm thick and offers excellent energy conversion/storage performance, cyclic stability, and mechanical flexibility. The results of this project will lay the foundation for the development of next-generation wearable electronics.