Effectiveness of active middle ear implant placement methods in pathological conditions: basilar membrane vibration simulation.

Active middle ear implants (AMEI) amplify mechanical vibrations in the middle ear and transmit them to the cochlea. The AMEI includes a floating mass transducer (FMT) that can be placed using two different surgical approaches: "oval window (OW) vibroplasty" and "round window (RW) vibroplasty." The OW and RW are windows located on the cochlea. Normally, sound stimulus is transmitted from the middle ear to cochlea via the OW. RW vibroplasty has been suggested as an alternative method due to the difficulty of applying OW vibroplasty in patients with ossicle dysfunction. Several reports compare the advantages of each approach through pre and postoperative hearing tests. However, quantitatively assessing the treatment effect is challenging due to individual differences in pathologies. This study investigates the vibration transmission efficiency of each surgical approach using a finite-element model of the human cochlea. Vibration of the basilar membrane (BM) of the cochlea is simulated by applying the stimulus through the OW or RW. Pathological conditions, such as impaired stapes mobility, are simulated by increasing the stiffness of the stapedial annular ligament. RW closure due to chronic middle ear diseases is a common clinical occurrence and is simulated by increasing the stiffness of the RW membrane in the model. The results show that the vibration amplitude of the BM is larger when the stimulus is applied to the RW compared to the OW, except for cases of RW membrane ossification. The difference in these amplitudes is particularly significant when stapedial mobility is limited. These results suggest that RW vibroplasty would be advantageous, especially in cases of accompanying stapedial mobility impairment. Additionally, it is suggested that transitioning to OW vibroplasty could still ensure a sufficient level of vibratory transmission efficiency when placing the FMT on the RW membrane is difficult due to anatomical problems in the tympanic cavity or confirmed severe pathological conditions around the RW.

Optical measurements of eardrum vibrations and sound propagation in the ear canal for the fitting of active middle ear implants.

BACKGROUND: Middle ear implants (MEI) are for the medical rehabilitation of the hearing function in case of sound conduction hearing losses as well as cochlear hearing losses and their combinations. OBJECTIVES: An objective tool to reach the best fitting of the external worn sound processors is essential for patients who do not want or cannot participate in the fitting process. METHODS: In addition to Laser-Doppler-Vibrometry (LDV) measurement, the sound pressure was measured distant to the eardrum to attain additional information for comparison. Three groups of patients with different middle ear characteristics were examined. RESULTS: Because of the large spreading of measuring results even within a patient group with similar eardrum and middle ear conditions it is difficult to develop characteristic diagrams which represent the mean values of eardrum displacements with different sound processor adjustments being the base for normative data courses. CONCLUSIONS AND SIGNIFICANCE: The LDV measurements can be used as a tool for fitting sound processors by finding individual maximum eardrum velocities in the frequency range 125 Hz to 8 kHz. In comparison to acoustical measurements the optical measurements have advantages concerning lower variations of measurement values, higher spectral resolution, and robustness against disturbing acoustic noise, especially at low frequencies.

Intraoperative quantification of floating mass transducer coupling quality in active middle ear implants: a multicenter study.

PURPOSE: Evaluating the effectiveness of intraoperative auditory brainstem responses (ABRs) to stimulation by the Vibrant Soundbridge (VSB) active middle ear implant for quantifying the implant's floating mass transducer (FMT) coupling quality. METHODS: In a diagnostic multicentric study, patients (> 18 years) who received a VSB with different coupling modalities were included. Pre- and postoperative bone conduction thresholds, intraoperative VSB-evoked ABR thresholds (VSB-ABR) using a modified audio processor programmed to preoperative bone conduction thresholds, postoperative vibrogram thresholds, and postoperative VSB-ABR thresholds were measured. Coupling quality was calculated from the difference between the pure tone average at 1000, 2000, and 4000 Hz (3PTA) vibrogram and postoperative 3PTA bone conduction thresholds. RESULTS: Twenty-three patients (13 males, 10 females, mean age 56.6 (± 12.5) years) were included in the study. Intraoperative VSB-ABR response thresholds could be obtained in all except one patient where the threshold was > 30 dB nHL. Postoperatively, an insufficient coupling of 36.7 dB was confirmed in this patient. In a Bland-Altman analysis of the intraoperative VSB-ABRs and coupling quality, the limits of agreement exceeded ± 10 dB, i.e., the maximum allowed difference considered as not clinically important but the variation was within the general precision of auditory brainstem responses to predict behavioral thresholds. Five outliers were identified. In two patients, the postoperative VSB-ABR thresholds were in agreement with the coupling quality, indicating a change of coupling before the postoperative testing. CONCLUSION: The response thresholds recorded in this set-up have the potential to predict the VSB coupling quality and optimize postoperative audiological results.

Successive ipsilateral surgery of Vibrant Soundbridge and Bonebridge devices for congenital bilateral conductive hearing loss: a case report.

The Bonebridge and Vibrant Soundbridge systems are semi-implanted hearing devices, which have been widely applied in patients with congenital conductive hearing loss. However, comparison between these two hearing devices is rare, especially in the same patient. We report a 23-year-old man who underwent successive implantation of Vibrant Soundbridge and Bonebridge devices in the same ear because of dysfunction of the Vibrant Soundbridge. We provide insight on the patient's experience and compare the audiological and subjective outcomes of satisfaction.

Outcome prediction for Bonebridge candidates based on audiological indication criteria.

OBJECTIVE: To re-evaluate current indication criteria and to estimate the audiological outcomes of patients with Bonebridge bone conduction implants based on preoperative bone conduction thresholds. METHODS: We assessed the outcome of 28 subjects with either conductive or mixed hearing loss (CMHL) or single-sided deafness (SSD) who were undergoing a Bonebridge implantation. We used linear regression to evaluate the influence of preoperative bone conduction thresholds of the better/poorer ear, indication group, and language (German- and French-speaking patients) on aided sound field thresholds. In addition, aided word recognition scores at 65dB sound pressure level were fit with a logistic model that included preoperative bone conduction thresholds of the better/poorer ear, indication group, and language as effects. RESULTS: We found that both aided sound field thresholds and word recognition were correlated with the preoperative bone conduction thresholds of the better hearing ear. No correlation between audiological outcomes and the preoperative bone conduction thresholds of the poorer ear, language, or indication group was found. CONCLUSION: Bone conduction thresholds of the better hearing ear should be used to estimate the outcome of patients undergoing Bonebridge implantation. We suggest the indication criteria for Bonebridge candidates considering maximal bone conduction thresholds of the better ear at 38dB HL to achieve an aided sound field threshold of at least 30dB hearing level and an aided word recognition score of at least 75% for monosyllabic words.

Vibrant Soundbridge Implantation: Floating Mass Transducer Coupled with the Stapes Head and Embedded in Fat.

Subtotal petrosectomy may be performed for refractory chronic middle ear diseases, such as massive cholesteatoma or recurrent otitis media. It involves permanent obliteration of the operative cavity, thus precluding the chance to restore conductive hearing via traditional inertial ossicular prostheses. The Vibrant Soundbridge (VSB) is an alternative option for hearing rehabilitation. Vibrant energy is delivered into the inner ear via a floating mass transducer (FMT), which can be coupled with any part of the middle ear acoustic transmission structure. To restore the hearing of a young woman with cholesteatoma, we combined subtotal petrosectomy with obliteration of the cavity and VSB implantation with an FMT coupled to the stapes head. Two years of follow-up demonstrated excellent auditory rehabilitation, improved sound source localization ability, and a lower speech recognition threshold. This study showed that the FMT works well in an obliterated cavity, and the experience acquired through this successful exploration is worth disseminating.

Influence of backside loading on the floating mass transducer: An in vitro experimental study.

HYPOTHESIS: The vibration of the floating mass transducer (FMT) of a single active middle-ear implant (AMEI) is distinctly influenced by the properties of the material coupled to its back side. BACKGROUND: In round window vibroplasty, the FMT needs to be padded against the surrounding bone opposite from the round window membrane. This represents one factor influencing its performance as a round window driver. Therefore, we examined the effects of different materials linked to the back side of an FMT on its vibration range. METHODS: The back side of an FMT was glued to a silicone cylinder 1.0 mm in diameter and 1.0 mm - 1.5 mm in length and of 40A, 50A or 70A Shore hardness; to cartilage of equivalent size; or to a round window soft coupler (RWSC), all firmly fixed on a steel plate. The vibrations were determined by a laser Doppler vibrometer (LDV) measuring the velocity of the centre point on the front side of the FMT. RESULTS: The materials on the back side of the FMT significantly influenced the vibration range of the FMT. The RWSC and silicone of 40A Shore hardness allowed for the highest detected velocities, while cartilage led to a distinct reduction similarly to 70A silicone. CONCLUSION: The coupling on the back side of an FMT distinctly affects its vibration range. In this regard, the RWSC and silicone of 40A Shore hardness yield the least impairment of vibration. Thus, the RWSC may be a feasible option in round window vibroplasty when additionally connected to the FMT opposite from the round window membrane.

Minimally invasive laser vibrometry (MIVIB) with a floating mass transducer - A new method for objective evaluation of the middle ear demonstrated on stapes fixation.

Ossicular fixation through otosclerosis, chronic otitis media and other pathologies, especially tympanosclerosis, are treated by surgery if hearing aids fail as an alternative. However, the best hearing outcome is often based on knowledge of the degree and location of the fixation. Objective methods to quantify the degree and position of the fixation are largely lacking. Laser vibrometry is a known method to detect ossicular fixation but clinical applicability remains limited. A new method, minimally invasive laser vibrometry (MIVIB), is presented to quantify ossicle mobility using laser vibrometry measurement through the ear canal after elevating the tympanic membrane, thus making the method feasible in minimally invasive explorative surgery. A floating mass transducer provides a clinically relevant transducer to drive ossicular vibration. This device was attached to the manubrium and drove vibrations at the same angle as the longitudinal axis of the stapes and was therefore used to assess ossicular chain mobility in a fresh-frozen temporal bone model with and without stapes fixation. The ratio between the umbo and incus long process was shown to be useful in assessing stapes fixation. The incus-to-umbo velocity ratio decreased by 15 dB when comparing the unfixated situation to stapes fixation up to 2.5 kHz. Such quantification of ossicular fixation using the incus-to-umbo velocity ratio would allow quick and objective analysis of ossicular chain fixations which will assist the surgeon in surgical planning and optimize hearing outcomes.

The Vibrant Soundbridge® middle ear implant: A historical overview.

OBJECTIVE: To present a historical overview of the Vibrant Soundbridge® (VSB) middle ear implant (MEI), since its beginning in the 1990s to date and to describe its course and contemplate what it might become in the future. HISTORY: MEIs started to take form in researchers' mind in the 1930s with the first experiment of Wilska. In the 1970s, several devices, such as the Goode and Perkins', the Maniglia's, or the Hough and Dormer's were created but remained prototypes. It is only in the 1990s the devices that emerged remained on the market. In 1994, Symphonix, Inc. was created and aimed to manufacture and commercialize its semi-implantable MEI, the VSB. The principle of the VSB lies on a direct drive of the sound to a vibratory structure of the middle ear through an electromagnetic transducer, the floating mass transducer (FMT). The particularity of the system VSB is the simplicity of the transducer which is made of both the magnet and the coil; thus, the FMT, fixed on a vibrating middle ear structure, mimics the natural movement of the ossicular chain by moving in the same direction. The goal of the VSB was to give an alternative to patients with mild-to-severe sensorineural hearing loss who could not wear hearing aids (HAs) or who were unsatisfied conventional HA users. Subsequent to Tjellström's experiment in 1997, implantations started to include etiologies such as otosclerosis, radical mastoidectomy, failed ossiculoplasty/tympanoplasty, and atresia. Nowadays, the VSB, with more than 20 years of experience, is the oldest and most used middle ear implant worldwide. It is well acknowledged that the straightforward design and reliability of the transducer have certainly contributed to the success of the device.

A comparative study of MED-EL FMT attachment to the long process of the incus in intact middle ears and its attachment to disarticulated stapes head.

The Vibrant Soundbridge© (VSB) active middle-ear implant provides an effective treatment for mild-to-severe sensorineural hearing loss in the case of normal middle ear anatomy and mixed hearing loss in middle ear malformation. The VSB floating mass transducer (FMT), with proper couplers, can be installed on various structures of the ossicular chain, e.g., the short and long process of the incus, the stapes head, and the stapes footplate. A long process (LP) coupler is most commonly used for FMT attachment to the long process of the incus with intact ossicular chain, while CliP and Bell couplers are two standardized and reliable methods for FMT attachment to the stapes head with missing incus and malleus. However, the difference and relationship of the vibration properties among these three FMT couplers remain unclear. In the present study, the stapes footplate velocity responses of the LP, CliP, and Bell couplers have been investigated in eight fresh temporal bones (TBs) to evaluate the vibration properties of these three couplers. Normal and reconstructed middle ear transfer functions (METFs) were determined from laser Doppler vibrometer (LDV) measurements. A mastoidectomy and a posterior tympanotomy were performed to expose the ossicular chain. The METFs of the normal middle ear and middle ear with LP-FMT-coupler were compared under acoustic stimulation, thus the mass effect of the FMT with LP coupler was evaluated. Additional comparisons were made between the stapes footplate vibrations of the LP-FMT-coupler (with the intact ossicular chain at the long process of the incus), CliP-FMT-coupler and Bell-FMT-coupler on the stapes head (after incus and malleus removed) under active electromechanical stimulation. After the installation of CliP-FMT-coupler and Bell-FMT-coupler to the middle ear, the average velocity amplitude of the stapes footplate, comparing to the LP-FMT-coupler, was about 15 dB higher between 1 and 6 kHz, and 10 dB lower at about 0.5 kHz. Quantitatively, there was no significant difference between the CliP-FMT-coupler and Bell-FMT-coupler. According to our study, installation of CliP-FMT-coupler or Bell-FMT-coupler on the stapes head provides considerable improvement of the middle ear mechanical and functional responses, comparing with the LP-FMT-coupler in the temporal bone experiments. Moreover, the installation of the Bell-FMT-coupler to the stapes head produces essentially the same footplate velocity responses in comparison to the CliP-FMT-coupler.

Anatomic measurements of the posterior tympanum related to the round window vibroplasty in congenital aural atresia and stenosis patients.

CONCLUSIONS: With the aggravation of the external auditory canal malformation, the size of extra-niche fossa became smaller, providing concrete data and valuable information for the better design, selecting and safer implantation of the transducer in the area of round window niche. Three-dimensional measurements and assessments before surgery might be helpful for a safer surgical approach and implantation of a vibrant soundbridge. OBJECTIVES: The aim of this study was to investigate whether differences exist in the morphology of the posterior tympanum related to the round window vibroplasty among congenital aural atresia (CAA), congenital aural stenosis (CAS), and a normal control group, and to analyze its effect on the round window implantation of vibrant soundbridge. METHODS: CT images of 10 normal subjects (20 ears), 27 CAS patients (30 ears), and 25 CAA patients (30 ears) were analyzed. The depth and the size of outside fossa of round window niche related to the round window vibroplasty (extra-niche fossa)and the distances between the center of round window niche and extra-niche fossa were calculated based on three-dimensional reconstruction using mimics software. Finally, the data were analyzed statistically. RESULTS: The size of extra-niche fossa in the atresia group was smaller than in the stenosis group (p < 0.05); furthermore, the size of extra-niche fossa in the stenosis group was smaller than that of the control group (p < 0.05). There was no statistically significant difference of the depth of extra-niche fossa among different groups.

A clinical experience of 'STAMP' plate-guided Bonebridge implantation.

CONCLUSION: The surface template-assisted marker positioning (STAMP) method is useful for successful Bonebridge™ (BB) implantation on a planned site while avoiding dangerous positions. OBJECTIVES: To confirm the usefulness of the STAMP method for the safe operation of BB. METHODS: From a patient's temporal bone CT data, a guide plate and confirmation plate were generated by the STAMP method. The guide plate is used to mark the correct place for implantation, while the confirmation plate lets us know the correct angle and depth of the hole. RESULTS: With the guide plate, the correct place for BB implantation was easily found. The hole was made to be an appropriate size with the confirmation plate while exposing only a small part of sigmoid sinus as simulated. Finally, the BB implant was successfully placed exactly at the planned site.

Consensus statement on round window vibroplasty.

OBJECTIVE: This study aimed to review current knowledge regarding implantation of the Vibrant Soundbridge floating mass transducer (FMT) at the round window (round window vibroplasty) as well as to form a consensus on steps for a reliable, stable surgical procedure. DATA SOURCES: Review of the literature and experimental observations by the authors. CONCLUSION: Round window (RW) vibroplasty has been established as a reliable procedure that produces good and stable results for patients with conductive or mixed hearing loss. The experience gained over the past few years of the authors' more than 200 implantations has led to consensus on several key points: (1) a wide and bloodless access to the middle ear with facial nerve monitoring, (2) the careful and correct identification and exposure of the round window membrane, (3) a good setup for efficient energy transition of the FMT, namely, perpendicular placement of the FMT with no contact to bone and the placement of cartilage behind the FMT to create a preloaded "spring" function, and (4) 4 points of FMT fixation: a rim of the round window bony overhang left intact both anterior and posterior to the FMT, conductor link stabilization, and cartilage behind the FMT. In addition, the FMT should be covered with soft tissue.

Simulations and Measurements of Human Middle Ear Vibrations Using Multi-Body Systems and Laser-Doppler Vibrometry with the Floating Mass Transducer.

The transfer characteristic of the human middle ear with an applied middle ear implant (floating mass transducer) is examined computationally with a Multi-body System approach and compared with experimental results. For this purpose, the geometry of the middle ear was reconstructed from µ-computer tomography slice data and prepared for a Multi-body System simulation. The transfer function of the floating mass transducer, which is the ratio of the input voltage and the generated force, is derived based on a physical context. The numerical results obtained with the Multi-body System approach are compared with experimental results by Laser Doppler measurements of the stapes footplate velocities of five different specimens. Although slightly differing anatomical structures were used for the calculation and the measurement, a high correspondence with respect to the course of stapes footplate displacement along the frequency was found. Notably, a notch at frequencies just below 1 kHz occurred. Additionally, phase courses of stapes footplate displacements were determined computationally if possible and compared with experimental results. The examinations were undertaken to quantify stapes footplate displacements in the clinical practice of middle ear implants and, also, to develop fitting strategies on a physical basis for hearing impaired patients aided with middle ear implants.

Effect of Fixing Different Positions of the Wire Linked to FMT on FMT Vibration / 听力学及言语疾病杂志

Objective To find an optimum fixed position on the wire linked to floating mass transducer(FMT)by measuring FMT vibration with laser doppler vibrometer(LDV).Methods Fixing three points on the wire linked with FMT:10 mm,5 mm away from the FMT and the end of the wire.The vibration intensity of the FMT was measured with LDV when the FMT received continuous pure-tone stimuli at 100 and 80 dB SPL,respectively.Results The vibration amplitude of FMT was the highest at 1.5 and 2 kHz,and the lowest at 0.25 and 8 kHz when the FMT received pure-tone stimuli from 0.25 to 8 kHz.When the wire was fixed at/above different points,the FMT produced similar positive vibration amplitude.Conclusion The wire is fixed linked with FMT at/above three different points,FMT produces similar vibration amplitude when receiving pure tone stimuli.