Electroacoustic evaluation of the bone conduction transducer B250 for vestibular and hearing diagnostics in comparison with Radioear B71 and B81.

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.

Objective verification of audibility in bone conduction devices.

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.

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.

Ankle Audiometry: A Clinical Test for the Enhanced Hearing Sensitivity for Body Sounds in Superior Canal Dehiscence Syndrome.

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.

A novel method for objective in-situ measurement of audibility in bone conduction hearing devices - a pilot study using a skin drive BCD.

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.

Long-term follow-up and review of the Bone Conduction Implant.

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.

Bone Conduction Stimulated VEMP Using the B250 Transducer.

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.

Three-Year Follow-Up with the Bone Conduction Implant.

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.

Effects of Simulated and Profound Unilateral Sensorineural Hearing Loss on Recognition of Speech in Competing Speech.

OBJECTIVES: Unilateral hearing loss (UHL) is a condition as common as bilateral hearing loss in adults. Because of the unilaterally reduced audibility associated with UHL, binaural processing of sounds may be disrupted. As a consequence, daily tasks such as listening to speech in a background of spatially distinct competing sounds may be challenging. A growing body of subjective and objective data suggests that spatial hearing is negatively affected by UHL. However, the type and degree of UHL vary considerably in previous studies. The aim here was to determine the effect of a profound sensorineural UHL, and of a simulated UHL, on recognition of speech in competing speech, and the binaural and monaural contributions to spatial release from masking, in a demanding multisource listening environment. DESIGN: Nine subjects (25 to 61 years) with profound sensorineural UHL [mean pure-tone average (PTA) across 0.5, 1, 2, and 4 kHz = 105 dB HL] and normal contralateral hearing (mean PTA = 7.2 dB HL) were included based on the criterion that the target and competing speech were inaudible in the ear with hearing loss. Thirteen subjects with normal hearing (19 to 60 years; mean left PTA = 4.1 dB HL; mean right PTA = 5.5 dB HL) contributed data in normal and simulated "mild-to-moderate" UHL conditions (PTA = 38.6 dB HL). The main outcome measure was the threshold for 40% correct speech recognition in colocated (0°) and spatially and symmetrically separated (±30° and ±150°) competing speech conditions. Spatial release from masking was quantified as the threshold difference between colocated and separated conditions. RESULTS: Thresholds in profound UHL were higher (worse) than normal hearing in separated and colocated conditions, and comparable to simulated UHL. Monaural spatial release from masking, that is, the spatial release achieved by subjects with profound UHL, was significantly different from zero and 49% of the magnitude of the spatial release from masking achieved by subjects with normal hearing. There were subjects with profound UHL who showed negative spatial release, whereas subjects with normal hearing consistently showed positive spatial release from masking in the normal condition. The simulated UHL had a larger effect on the speech recognition threshold for separated than for colocated conditions, resulting in decreased spatial release from masking. The difference in spatial release between normal-hearing and simulated UHL conditions increased with age. CONCLUSIONS: The results demonstrate that while recognition of speech in colocated and separated competing speech is impaired for profound sensorineural UHL, spatial release from masking may be possible when competing speech is symmetrically distributed around the listener. A "mild-to-moderate" simulated UHL decreases spatial release from masking compared with normal-hearing conditions and interacts with age, indicating that small amounts of residual hearing in the UHL ear may be more beneficial for separated than for colocated interferer conditions for young listeners.

The effect of an active transcutaneous bone conduction device on spatial release from masking.

Objective: The aim was to quantify the effect of the experimental active transcutaneous Bone Conduction Implant (BCI) on spatial release from masking (SRM) in subjects with bilateral or unilateral conductive and mixed hearing loss.Design: Measurements were performed in a sound booth with five loudspeakers at 0°, +/-30° and +/-150° azimuth. Target speech was presented frontally, and interfering speech from either the front (co-located) or surrounding (separated) loudspeakers. SRM was calculated as the difference between the separated and the co-located speech recognition threshold (SRT).Study Sample: Twelve patients (aged 22-76 years) unilaterally implanted with the BCI were included.Results: A positive SRM, reflecting a benefit of spatially separating interferers from target speech, existed for all subjects in unaided condition, and for nine subjects (75%) in aided condition. Aided SRM was lower compared to unaided in nine of the subjects. There was no difference in SRM between patients with bilateral and unilateral hearing loss. In aided situation, SRT improved only for patients with bilateral hearing loss.Conclusions: The BCI fitted unilaterally in patients with bilateral or unilateral conductive/mixed hearing loss seems to reduce SRM. However, data indicates that SRT is improved or maintained for patients with bilateral and unilateral hearing loss, respectively.

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.

Effect of transducer attachment on vibration transmission and transcranial attenuation for direct drive bone conduction stimulation.

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.

Nasal sound pressure as objective verification of implant in active transcutaneous bone conduction devices.

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.

Robustness and lifetime of the bone conduction implant - a pilot study.

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.

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.

Horizontal sound localisation accuracy in individuals with conductive hearing loss: effect of the bone conduction implant.

OBJECTIVE: The objective of this study is to quantify the effect of the Bone Conduction Implant (BCI) on sound localisation accuracy in subjects with conductive hearing loss (CHL). DESIGN: The subjects were tested in a horizontal sound localisation task in which localisation responses were objectively obtained by eye-tracking, in a prospective, cross-sectional design. The tests were performed unaided and unilaterally aided. The stimulus used had a spectrum similar to female speech and was presented at 63 and 73 dB SPL. The main outcome measure was the error index (EI), ranging from 0 to 1 (perfect to random performance). STUDY SAMPLE: Eleven subjects (aged 21-75 years, five females) with BCI participated in the study. Their mixed/conductive hearing loss was either unilateral (n = 5) or bilateral (n = 6). RESULTS: Three of five subjects (60%) with unilateral CHL, and four of six subjects (67%) with bilateral CHL showed significantly improved sound localisation when using a unilateral BCI (p < .05). For the subjects with bilateral CHL, a distinct linear relation between aided sound localisation and hearing thresholds in the non-implant ear existed at 73 dB SPL (18% decrease in the EI per 10 dB decrease in pure-tone average, r = 0.98, p < .001). CONCLUSIONS: Individuals with mixed/conductive hearing loss may benefit from a unilateral BCI in sound localisation.

Direct bone conduction stimulation: Ipsilateral effect of different transducer attachments in active transcutaneous devices.

Active transcutaneous bone conduction devices, where the transducer is implanted, are used for rehabilitation of hearing impaired patients by directly stimulating the skull bone. The transducer and the way it is attached to the bone play a central role in the design of such devices. The actual effect of varying the contact to bone has not been addressed yet. The aim of this study is therefore to compare how different attachment methods of the transducer to the bone for direct stimulation affect the ear canal sound pressure and vibration transmission to the ipsilateral cochlea. Three different attachments to the bone were tested: (A) via a flat small-sized surface, (B) via a flat wide surface and (C) via two separated screws. Measurements were done on four human heads on both sides. The attachments were compared in terms of induced cochlear promontory velocity, measured by a laser Doppler vibrometer, and ear canal sound pressure, measured by a low noise microphone. A swept sine stimulus was used in the frequency range 0.1-10 kHz. On an average level, the attachment method seems to affect the transmission mainly at frequencies above 5 kHz. Furthermore, the results suggest that a smaller contact surface might perform better in terms of transmission of vibrations at mid and high frequencies. However, when considering the whole frequency range, average results from the different attachment techniques are comparable.

Vibrotactile Thresholds on the Mastoid and Forehead Position of Deaf Patients Using Radioear B71 and B81.

OBJECTIVES: The main objective of this study was to measure the vibrotactile thresholds on the mastoid process and forehead positions using patients with bilateral deafness and to compare the results from the two bone conduction vibrators Radioear B71 and B81. DESIGN: There is a possibility that the vibrotactile sensation on the skin makes it difficult to discriminate between sound and vibration. The risk is highest for patients who have bone conduction hearing thresholds in proximity to or worse than their vibrotactile thresholds. All measurements were performed similar to regular bone conduction threshold testing using an audiometer-driven bone conduction vibrator and pulsed warble tones, but the patients were instructed to respond only when feeling vibrations of the bone conduction vibrator instead of when hearing sound. Both the posterior forehead position and the mastoid process position on the temporal bone were tested for comparative reasons. In total, 16 patients participated in the study, 31% females and 69% males of age 29 to 77 years. All subjects were cochlear implant recipients, either uni- or bilaterally implanted. They were selected based on their audiogram data showing unmeasurable unaided hearing. RESULTS: The force level at which the vibrotactile thresholds were reached, increased with frequency from 125 up to 500 Hz, but remained constant for higher frequencies up to 2 kHz. A statistically significant difference was found between the 2 devices at 125 Hz at both the mastoid process and forehead position, where the vibrotactile threshold seem to be more sensitive for B71, possibly due to contribution of distortion components. There was no statistically significant difference in vibrotactile thresholds between the mastoid process and forehead position in absolute values (force level in dB re 1 µN), but in terms of hearing levels (dB HL) there was an average difference of 10 and 9 dB for B71 and B81, respectively. CONCLUSIONS: The results indicate that the vibrotactile thresholds can be confounded with bone conduction hearing thresholds measurements up to 500 Hz when using a standard audiometer and in particular when measuring on the forehead position.

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.