The bone conduction implant - a review and 1-year follow-up.

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.

Electro-acoustic performance of the new bone vibrator Radioear B81: a comparison with the conventional Radioear B71.

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 Vin = 6 VRMS) 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 (α = 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.

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.

The Validation of a Simultaneous Ocular and Cervical VEMP Recording Protocol to Unilateral AC Stimuli.

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.

VEMP using a new low-frequency bone conduction transducer.

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.

Audiometric Comparison Between the First Patients With the Transcutaneous Bone Conduction Implant and Matched Percutaneous Bone Anchored Hearing Device Users.

HYPOTHESIS: The transcutaneous bone conduction implant (BCI) is compared with bone-anchored hearing aids (BAHAs) under the hypothesis that the BCI can give similar rehabilitation from an audiological as well as patient-related point of view. BACKGROUND: Patients suffering from conductive and mixed hearing losses can often benefit more from rehabilitation using bone conduction devices (BCDs) rather than conventional air conduction devices. The most widely used BCD is the percutaneous BAHA, with a permanent skin-penetrating abutment. To overcome issues related to percutaneous BCDs, the trend today is to develop transcutaneous devices, with intact skin. The BCI is an active transcutaneous device currently in a clinical trial phase. A potential limitation of active transcutaneous devices is the loss of power in the induction link over the skin. To address this issue, countermeasures are taken in the design of the BCI, which is therefore expected to be as effective as percutaneous BCDs. METHODS: An early observational study with a matched-pair design was performed to compare BCI and BAHA groups of patients over several audiometric measurements, including speech audiometry and warble tones thresholds with and without the device. Additionally, questionnaires were used to assess the general health condition, benefit, and satisfaction level of patients. RESULTS: No statistically significant difference was detected in any of the audiological measurements. The outcome of patient-related measurements was slightly superior for BCI in all subscales. CONCLUSION: Results confirm the initial hypothesis of the study: the BCI seems to be capable of providing as good rehabilitation as percutaneous devices for indicated patients.

Magnetic resonance imaging investigation of the bone conduction implant - a pilot study at 1.5 Tesla.

PURPOSE: 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. METHODS AND MATERIALS: One implant was placed on the head of a test person at the position corresponding to the normal position of an implanted BCI and applied with a static pressure using a bandage and scanned in a 1.5 Tesla MRI camera. Scanning was performed both with and without the implant, in three orthogonal planes, and for one spin-echo and one gradient-echo pulse sequence. Implant functionality was verified in-between the scans using an audio processor programmed to generate a sequence of tones when attached to the implant. Objective verification was also carried out by measuring MPO and THD on a skull simulator as well as retention force, before and after MRI. RESULTS: It was found that the exposure of 1.5 Tesla MRI only had a minor effect on the MPO, ie, it decreased over all frequencies with an average of 1.1±2.1 dB. The THD remained unchanged above 300 Hz and was increased only at lower frequencies. The retention magnet was demagnetized by 5%. The maximum image artifacts reached a distance of 9 and 10 cm from the implant in the coronal plane for the spin-echo and the gradient-echo sequence, respectively. The test person reported no MRI induced sound from the implant. CONCLUSION: This pilot study indicates that the present BCI may withstand 1.5 Tesla MRI with only minor effects on its performance. No MRI induced sound was reported, but the head image was highly distorted near the implant.

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.

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.