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\u27 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

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 \ub1 0.22 N (mean \ub1 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

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

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

Direct bone conduction stimulation: effect of different transducer attachments

Objective(s): When choosing a method to implant a transducer for direct bone conduction stimulation, several options are available with the trade-off being, among other aspects, between achieving a robust contact to the bone and keeping an open possibility for potential future explantation. The aim of this study is to compare how different attachment methods for direct bone conduction stimulation can affect the vibrations transmission to the cochleae. The ultimate goal is to gain more insights on the dynamical properties of the skull to apply them to the design and optimization of bone conduction devices for hearing rehabilitation.Study design:Experimental.Patients:Measurements were performed on four human heads. The tympanic membrane, the malleus and the incus were removed to expose the cochlear promontory on both sides of each subject. The subjects have not undergone any previous surgery as verified by visual inspection.Methods:Three different attachments are tested on eight sides: (A) flat small-sized surface, (B) flat wide surface and (C) two separated screws. The different typologies of contact to bone are established by three dummy implants and an adapter to attach the transducer giving a swept sine stimulus from 0.1 to 10 kHz. The response is evaluated in terms of cochlear promontory acceleration and ear canal sound pressure level (ECSP). The measurement setup consists of the following parts: human head, transducer with adaptor (to apply the stimulus), signal generator and analyzer (to drive the transducer and receive the recorded data), Laser Doppler Vibrometer (LDV, measuring the cochlear promontory acceleration), video to USB converter (to couple the built-in camera of LDV with the computer), microphones (to measure ECSP) and laptop (to save data).Results:Average results show slightly higher ECSP level and cochlear promontory acceleration for attachment A compared to attachment B especially at frequencies above 1 kHz. An improvement in transmission is achieved with attachment C compared to B in the frequency range 5–7 kHz, where the levels differ by nearly 10 dB both ipsi- and contralaterally. In the same frequency range, the transmission from attachment C appears to be slightly higher relative to attachment A as well, however no statistical significance is found. The comparison between attachment A and C is not straightforward due to high variability over frequencies and sometimes contradictory results between LDV and ECSP measurements.Conclusion:On an average level, the screw stimulation technique seems to improve the transmission at frequencies above 5 kHz. However,, when considering the whole frequency range, average results from the different attachment techniques are comparable. Still, conclusions for single subjects should be drawn with care as measurements show a very high inter-subject variability

Percutaneous versus transcutaneous bone conduction implant system: a feasibility study on a cadaver head.

OBJECTIVE: Percutaneous bone-anchored hearing aid (BAHA) is an important rehabilitation alternative for patients who have conductive or mixed hearing loss. However, these devices use a percutaneous and bone-anchored implant that has some drawbacks reported. A transcutaneous bone conduction implant system (BCI) is proposed as an alternative to the percutaneous system because it leaves the skin intact. The BCI transmits the signal to a permanently implanted transducer with an induction loop system through the intact skin. The aim of this study was to compare the electroacoustic performance of the BAHA Classic-300 with a full-scale BCI on a cadaver head in a sound field. The BCI comprised the audio processor of the vibrant sound bridge connected to a balanced vibration transducer (balanced electromagnetic separation transducer). METHODS: Implants with snap abutments were placed in the parietal bone (Classic-300) and 15-mm deep in the temporal bone (BCI). The vibration responses at the ipsilateral and contralateral cochlear promontories were measured with a laser Doppler vibrometer, with the beam aimed through the ear canal. RESULTS: Results show that the BCI produces approximately 5 dB higher maximum output level and has a slightly lower distortion than the Classic-300 at the ipsilateral promontorium at speech frequencies. At the contralateral promontorium, the maximum output level was considerably lower for the BCI than for the Classic-300 except in the 1-2 kHz range, where it was similar. CONCLUSION: Present results support the proposal that a BCI system can be a realistic alternative to a BAHA

Percutaneous versus transcutaneous bone conduction implant system: a feasibility study on a cadaver head.

OBJECTIVE: Percutaneous bone-anchored hearing aid (BAHA) is an important rehabilitation alternative for patients who have conductive or mixed hearing loss. However, these devices use a percutaneous and bone-anchored implant that has some drawbacks reported. A transcutaneous bone conduction implant system (BCI) is proposed as an alternative to the percutaneous system because it leaves the skin intact. The BCI transmits the signal to a permanently implanted transducer with an induction loop system through the intact skin. The aim of this study was to compare the electroacoustic performance of the BAHA Classic-300 with a full-scale BCI on a cadaver head in a sound field. The BCI comprised the audio processor of the vibrant sound bridge connected to a balanced vibration transducer (balanced electromagnetic separation transducer). METHODS: Implants with snap abutments were placed in the parietal bone (Classic-300) and 15-mm deep in the temporal bone (BCI). The vibration responses at the ipsilateral and contralateral cochlear promontories were measured with a laser Doppler vibrometer, with the beam aimed through the ear canal. RESULTS: Results show that the BCI produces approximately 5 dB higher maximum output level and has a slightly lower distortion than the Classic-300 at the ipsilateral promontorium at speech frequencies. At the contralateral promontorium, the maximum output level was considerably lower for the BCI than for the Classic-300 except in the 1-2 kHz range, where it was similar. CONCLUSION: Present results support the proposal that a BCI system can be a realistic alternative to a BAHA

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