An earbud-type wearable (A hearable) with vital parameter sensors for early detection and prevention of heat-stroke.

Heat-stroke has become a serious problem in Japan, especially for elderly citizens. For the early detection and prevention of heat-stroke, a wearable health monitor for in-ear use is developed which is subsequently called "Hearable". It aims to measure three vital parameters: Core body temperature, sweat rate and sweat or interstitial sodium ion (Na+) concentration. The eardrum is a good place to measure the core body temperature, because it is close to the carotid artery and the brain. We develop a hearable prototype and it consists of an audio earbud, a sensor earbud and a micro controller. Concerning the sensor earbud, a present prototype includes an eardrum (tympanic) temperature sensor and a sweat rate sensor and we implement two variants. Variant-1 focuses on the sweat rate sensing using a humidity & temperature sensor located close to the eardrum and Variant-2 focuses on the eardrum temperature sensing using an IR temperature sensor. Concerning the sweat rate sensing, unlike conventional sweat sensors, our prototypes do not include an air flow pump, which is typically used to determine the air flow rate. We demonstrate the accuracy of sweat rate sensing based on the air flow rate measured from the evaporation of defined amount of water. We use Variant-2 to demonstrate the monitoring of the eardrum temperature and the sweat rate to differentiate a calm state and jogging.

Technical design of a new bone conduction implant (BCI) system.

OBJECTIVE: The objective of this study is to describe the technical design and verify the technical performance of a new bone conduction implant (BCI) system. DESIGN: The BCI consists of an external audio processor and an implanted unit called the bridging bone conductor. These two units use an inductive link to communicate with each other through the intact skin in order to drive an implanted transducer. STUDY SAMPLE: In this study, the design of the full BCI system has been described and verified on a skull simulator and on real patients. RESULTS: It was found that the maximum output force (peak 107 dB re 1 µN) of the BCI is robust for skin thickness range of 2-8 mm and that the total harmonic distortion is below 8% in the speech frequency range for 70 dB input sound pressure level. The current consumption is 7.5 mA, which corresponds to 5-7 days use with a single battery. CONCLUSIONS: This study shows that the BCI is a robust design that gives a sufficiently high output and an excellent sound quality for the hearing rehabilitation of indicated patients.

New developments in bone-conduction hearing implants: a review.

The different kinds of bone-conduction devices (BCDs) available for hearing rehabilitation are growing. In this paper, all BCDs currently available or in clinical trials will be described in categories according to their principles. BCDs that vibrate the bone via the skin are referred to as skin-drive devices, and are divided into conventional devices, which are attached with softbands, for example, and passive transcutaneous devices, which have implanted magnets. BCDs that directly stimulate the bone are referred to as direct-drive devices, and are further divided into percutaneous and active transcutaneous devices; the latter have implanted transducers directly stimulating the bone under intact skin. The percutaneous direct-drive device is known as a bone-anchored hearing aid, which is the BCD that has the largest part of the market today. Because of some issues associated with the percutaneous implant, and to some extent because of esthetics, more transcutaneous solutions with intact skin are being developed today, both in the skin-drive and in the direct-drive category. Challenges in developing transcutaneous BCDs are mostly to do with power, attachment, invasiveness, and magnetic resonance imaging compatibility. In the future, the authors assume that the existing percutaneous direct-drive BCD will be retained as an important rehabilitation alternative, while the transcutaneous solutions will increase their part of the market, especially for patients with bone-conduction thresholds better than 35 dB HL (hearing level). Furthermore, the active transcutaneous direct-drive BCDs appear to be the most promising systems, but to establish more detailed inclusion criteria, and potential benefits and drawbacks, more extensive clinical studies are needed.

The bone conduction implant: Clinical results of the first six patients.

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.

Study of the feasible size of a bone conduction implant transducer in the temporal bone.

HYPOTHESIS: The aim was to assess the temporal bone volume to determine the suitable size and position of a bone conduction implant (BCI) transducer. BACKGROUND: A BCI transducer needs to be sufficiently small to fit in the mastoid portion of the temporal bone for a majority of patients. The anatomical geometry limits both the dimension of an implanted transducer and its positions in the temporal bone to provide a safe and simple surgery. METHODS: Computed tomography (CT) scans of temporal bones from 22 subjects were virtually reconstructed. With an algorithm in MATLAB, the maximum transducer diameter as function of the maximum transducer depth in the temporal bone, and the most suitable position were calculated in all subjects. RESULTS: An implanted transducer diameter of 16 mm inserted at a depth of 4 mm statistically fitted 95% of the subjects. If changing the transducer diameter to 12 mm, a depth of 6 mm would fit in 95% of the subjects. The most suitable position was found to be around 20 mm behind the ear canal. CONCLUSION: The present BCI transducer casing, used in ongoing clinical trials, was designed from the results in this study, demonstrating that the present BCI transducer casing (largest diameter [diagonal]: 15.5 mm, height: 6.4 mm) will statistically fit more than 95% of the subjects. Hence, the present BCI transducer is concluded to be sufficiently small to fit most normal-sized temporal bones and should be placed approximately 20 mm behind the ear canal.

MRI induced torque and demagnetization in retention magnets for a bone conduction implant.

Performing magnetic resonance imaging (MRI) examinations in patients who use implantable medical devices involve safety risks both for the patient and the implant. Hearing implants often use two permanent magnets, one implanted and one external, for the retention of the external transmitter coil to the implanted receiver coil to achieve an optimal signal transmission. The implanted magnet is subjected to both demagnetization and torque, magnetically induced by the MRI scanner. In this paper, demagnetization and a comparison between measured and simulated induced torque is studied for the retention magnet used in a bone conduction implant (BCI) system. The torque was measured and simulated in a uniform static magnetic field of 1.5 T. The magnetic field was generated by a dipole electromagnet and permanent magnets with two different types of coercive fields were tested. Demagnetization and maximum torque for the high coercive field magnets was 7.7% ± 2.5% and 0.20 ± 0.01 Nm, respectively and 71.4% ± 19.1% and 0.18 ± 0.01 Nm for the low coercive field magnets, respectively. The simulated maximum torque was 0.34 Nm, deviating from the measured torque in terms of amplitude, mainly related to an insufficient magnet model. The BCI implant with high coercive field magnets is believed to be magnetic resonance (MR) conditional up to 1.5 T if a compression band is used around the skull to fix the implant. This is not approved and requires further investigations, and if removal of the implant is needed, the surgical operation is expected to be simple.

Bone conduction hearing sensitivity in normal-hearing subjects: transcutaneous stimulation at BAHA vs BCI position.

OBJECTIVE: Bone conduction (BC) stimulation closer to the cochlea has previously been shown to give higher cochlear promontory acceleration measured by laser Doppler vibrometry (LDV). This study is investigating whether stimulation closer to the cochlea also gives improved hearing sensitivity. Furthermore, the study compares shifts in hearing sensitivity (BC thresholds) and ear-canal sound pressure (ECSP). DESIGN: BC hearing thresholds and ECSP have been measured for stimulation at two positions: the existing bone-anchored hearing aid (BAHA) position, and a new bone conduction implant (BCI) position that is located closer to the cochlea. STUDY SAMPLE: The measurements were made on 20 normal-hearing subjects. RESULTS: Depending on frequency, the ipsilateral hearing threshold was 3-14 dB better, and the ipsilateral ECSP was 2-12 dB higher for the BCI than for the BAHA position, with no significant differences between threshold and ECSP shifts at group level for most frequencies, and individually only for some subjects. CONCLUSIONS: It was found that both the objective ECSP and the subjective hearing threshold measurements gave similar improvement as previous LDV measurements for stimulation closer to the cochlea. One exception was that the LDV measurements did not show the improved sensitivity for frequencies below 500 Hz found here.

The bone conduction implant--first implantation, surgical and audiologic aspects.

OBJECTIVE: To report on preoperative assessment, surgery, and audiologic outcome of the first patient implanted with the bone conduction implant (BCI). BACKGROUND: The BCI is a bone conduction hearing device with an intact skin solution where the transducer is implanted close to the ear canal opening. By avoiding a percutaneous screw attachment to the skull, the BCI is anticipated to reduce complications associated with the Bone-Anchored Hearing Aid (BAHA) solution. METHODS: The first patient to receive a BCI was a 42-year-old woman with a unilateral mixed hearing loss due to tympanosclerosis. Preoperative and postoperative cone beam computed tomography and a virtual planning tool for 3D reconstruction were used to optimize and control the position of the BCI in the mastoid. The transducer was placed in a 5-mm deep seating in the mastoid and secured with a titanium bar. Free field tone and speech audiometry were conducted to evaluate the audiologic outcome at baseline (1 month postoperatively) and 1 month after baseline. RESULTS: The BCI was placed in the position according to the preoperative 3D planning. On average, the tone thresholds improved by 30 dB, speech reception thresholds by 25.5 dB and speech signal-to-noise ratio by 9.7 dB. The surgical procedure was considered simple and safe. CONCLUSION: The BCI can be implanted by a safe and easy surgical procedure. 3D preoperative planning can be helpful to optimize the BCI position. The BCI is a realistic alternative to the BAHA.

Transmission of bone conducted sound - correlation between hearing perception and cochlear vibration.

The vibration velocity of the lateral semicircular canal and the cochlear promontory was measured on 16 subjects with a unilateral middle ear common cavity, using a laser Doppler vibrometer, when the stimulation was by bone conduction (BC). Four stimulation positions were used: three ipsilateral positions and one contralateral position. Masked BC pure tone thresholds were measured with the stimulation at the same four positions. Valid vibration data were obtained at frequencies between 0.3 and 5.0 kHz. Large intersubject variation of the results was found with both methods. The difference in cochlear velocity with BC stimulation at the four positions varied as a function of frequency while the tone thresholds showed a tendency of lower thresholds with stimulation at positions close to the cochlea. The correlation between the vibration velocities of the two measuring sites of the otic capsule was high. Also, relative median data showed similar trends for both vibration and threshold measurements. However, due to the high variability for both vibration and perceptual data, low correlation between the two methods was found at the individual level. The results from this study indicated that human hearing perception from BC sound can be estimated from the measure of cochlear vibrations of the otic capsule. It also showed that vibration measurements of the cochlea in cadaver heads are similar to that measured in live humans.

A vibration investigation of a flat surface contact to skull bone for direct bone conduction transmission in sheep skulls in vivo.

HYPOTHESIS: Bone conduction implant (BCI) attached with a flat surface contact will offer efficient and linear vibration transmission over time. BACKGROUND: Despite that percutaneous bone conduction devices (PBCD) are successful in treating patients with conductive hearing loss, there are some drawbacks related to the need of a permanent skin penetration. The BCI system is designed as an alternative to the PBCD because it leaves the skin intact. METHODS: BCI dummy implants were installed in 3 sheep skulls in vivo to study the vibration transmission characteristics over time. Mechanical point impedances and vibration transfer response functions of the BCI implants were measured at the time of surgery and after a healing period of 8 months. RESULTS: In 1 sheep both implants healed without complications. In the other 2 sheep, the implants were either partially loose or lost to follow up. In the sheep with stable implants, it was found by the resonance frequency shift of the mechanical point impedance that a firmer integration between the implant and bone tissue as seen in osseointegrated surfaces developed over time. It was also shown that the transcranial vibration transmission remains stable and linear. Providing bone chips in the contact between the implant and the bone did not enhance vibration transmission. The surgical procedure for installing the BCI dummy implants was uneventful. CONCLUSION: The mechanical point impedances and vibration transfer response functions indicate that the BCI implants integrate and that transmission conditions remain stable over time.

Analysis and design of RF power and data link using amplitude modulation of Class-E for a novel bone conduction implant.

This paper presents analysis and design of a radio frequency power and data link for a novel Bone Conduction Implant (BCI) system. Patients with conductive and mixed hearing loss and single-sided deafness can be rehabilitated by bone-anchored hearing aids (BAHA). Whereas the conventional hearing aids transmit sound to the tympanic membrane via air conduction, the BAHA transmits sound via vibrations through the skull directly to the cochlea. It uses a titanium screw that penetrates the skin and needs life-long daily care; it may cause skin infection and redness. The BCI is developed as an alternative to the percutaneous BAHA since it leaves the skin intact. The BCI comprises an external audio processor with a transmitter coil and an implanted unit called the bridging bone conductor with a receiver coil. Using amplitude modulation of the Class-E power amplifier that drives the inductive link, the sound signal is transmitted to the implant through the intact skin. It was found that the BCI can generate enough output force level for candidate patients. Maximum power output of the BCI was designed to occur at 5-mm skin thickness and the variability was within 1.5 dB for 1-8-mm skin thickness variations.

Feedback analysis in percutaneous bone-conduction device and bone-conduction implant on a dry cranium.

HYPOTHESIS: The bone-conduction implant (BCI) can use a higher gain setting without having feedback problems compared with a percutaneous bone-conduction device (PBCD). BACKGROUND: The conventional PBCD, today, is a common treatment for patients with conductive hearing loss and single-sided deafness. However, there are minor drawbacks reported related to the percutaneous implant and specifically poor high-frequency gain. The BCI system is designed as an alternative to the percutaneous system because it leaves the skin intact and is less prone to fall into feedback oscillations, thus allowing more high-frequency gain. METHODS: Loop gains of the Baha Classic 300 and the BCI were measured in the frequency range of 100 to 10,000 Hz attached to a Skull simulator and a dry cranium. The Baha and the BCI positions were investigated. The devices were adjusted to full-on gain. RESULTS: It was found that the gain headroom using the BCI was generally 0 to 10 dB better at higher frequencies than using the Baha for a given mechanical output. More specifically, if the mechanical output of the devices were normalized at the cochlear level the improvement in gain headroom with the BCI versus the Baha were in the range of 10 to 30 dB. CONCLUSION: Using a BCI, significantly higher gain setting can be used without feedback problems as compared with using a PBCD.

A novel bone conduction implant (BCI): engineering aspects and pre-clinical studies.

Percutaneous bone anchored hearing aids (BAHA) are today an important rehabilitation alternative for patients suffering from conductive or mixed hearing loss. Despite their success they are associated with drawbacks such as skin infections, accidental or spontaneous loss of the bone implant, and patient refusal for treatment due to stigma. A novel bone conduction implant (BCI) system has been proposed as an alternative to the BAHA system because it leaves the skin intact. Such a BCI system has now been developed and the encapsulated transducer uses a non-screw attachment to a hollow recess of the lateral portion of the temporal bone. The aim of this study is to describe the basic engineering principals and some preclinical results obtained with the new BCI system. Laser Doppler vibrometer measurements on three cadaver heads show that the new BCI system produces 0-10 dB higher maximum output acceleration level at the ipsilateral promontory relative to conventional ear-level BAHA at speech frequencies. At the contralateral promontory the maximum output acceleration level was considerably lower for the BCI than for the BAHA.