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INTRODUCTION: The Vibrant Soundbridge (VSB) is a semi-implantable hearing aid for patients with various types of hearing loss and has been available for over 25 years. Recently, new audio processors with advanced signal processing, noise reduction, and multi-microphone technology have appeared. The aim of this study is to compare the benefits of using the newest Samba 2 processor to the previous generation processors in a group of experienced VSB users. METHODS: There were 22 experienced VSB users (mean time of using VSB was 9 years, SD = 2) who had their processor (D404 or Amadé) upgraded to the newest model (Samba 2). The mean age of the subjects was 56 years (SD = 20). Assessments were made by free-field audiometry, speech reception in quiet and noise, and Patient-Reported Outcome Measures (PROMs). RESULTS: Hearing tests in free field showed statistically significant improvements in hearing sensitivity and speech discrimination in quiet and noise with the Samba 2 audio processor compared to the earlier technology. PROMs confirmed the benefits of using the newest audio processor and there was more satisfaction in terms of usability. CONCLUSIONS: Access to modern technology for VSB patients provides measurable benefits.

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BACKGROUND: The Carina system (Cochlear Ltd., Sydney, Australia) is a totally implantable device providing acoustic amplification in adult patients with moderate-to-severe sensorineural or mixed hearing loss. One of the main concerns about such a totally implantable device has been represented by the subcutaneous battery lifespan. The aim of this article is to report the analysis of battery performances in a series of Carina-implanted patients after a long follow up. METHODS: In this retrospective study, the technical data of a series of patients implanted with the Carina middle ear implant in our clinic have been analysed, extracting the data from the log of telemetric measures. RESULTS: The mean lifespan cutback was 0.43 h/years (from 0 to 0.71 h/year), with a strong negative significant correlation between the follow-up period and the percentage of battery residual lifespan. CONCLUSION: The lifespan of the Carina's battery seems consistent with the manufacturer statement of a pluri-decennial lifespan, avoiding the need of an early surgical substitution and providing a full day of use of the system even after up to 12 years from the implantation.

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The Envoy Esteem and the Carina system are the 2 totally implantable hearing devices. The Esteem is designed for patients with bilateral moderate to severe sensorineural hearing loss who have an unaided speech discrimination score of greater than and equal to 40%. The Carina system is designed for patients with moderate to severe sensorineural hearing loss or those with mixed hearing loss. The Esteem offers a technologically advanced method to provide improvements in hearing and is available in the United States, whereas the Carina system is currently not available in the United States.

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Hearing loss is common in the geriatric population. Most hearing loss is associated with presbycusis or age-related hearing loss, impacting one-third of individuals over 65 years and increasing in prevalence with age. Hearing loss impacts quality of life, psychological health, and cognition. Implantable auditory devices are an exceptional option to improve hearing and quality of life. Various implantable auditory devices have been implemented safely with significant improvement in communication and performance on auditory tasks. Counseling is essential to establishing realistic expectations. Rehabilitation may be required to optimize outcomes and auditory performance with use.

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OBJECTIVES: To evaluate hearing performance and safety measures in a large group of totally implantable active middle ear implant (AMEI) wearers. METHODS: Retrospective case review of 172 ears (166 patients) with sensorineural hearing loss undergoing implantation of a totally implantable AMEI. Pure-tone air and bone thresholds, pure-tone average, speech reception threshold (SRT), and word recognition scores (WRS) at phonetically balanced maximum and at 50 dB (WRS50) were assessed at baseline unaided, with a hearing aid (baseline aided [BLA]), with the implant at activation, and for best implant postoperative measurement. Adverse events were reviewed. RESULTS: Mean length of follow-up was 35.7 months. Compared to unaided, the implant provided significant gain at all frequencies through 6 kHz. Amount of gain was significantly better with the implant than BLA at 1,500 and 2,000 Hz (P ≤ .001). Implant SRT was also significantly improved compared to BLA (29.9 dB vs. 38.5 dB, P ≤ .001). At a 50-dB presentation level, WRS was significantly better with the implant than BLA (65.6% vs. 45.5%, P ≤ .001). Bone conduction thresholds were not affected by the implant. The most common adverse event was taste disturbance, which occurred in 39.1%. In subjects with preimplant tinnitus, 56.1% experienced resolution of their tinnitus. Revision surgery was required in 15.7%, and 4% were ultimately explanted. CONCLUSION: The implant provided significant hearing benefit compared to unaided and to the subjects' own hearing aids in most test categories, with minimal adverse events. Many subjects experienced complete resolution of their tinnitus after implantation. LEVEL OF EVIDENCE: 4 Laryngoscope, 128:2872-2878, 2018.

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SUMMARY: The aim of the present study was to assess the feasibility and utility of 3D printing technology in surgical planning of a transcutaneous bone-conduction hearing device (Bonebridge®) (BB), focusing on the identification of the proper location and placement of the transducer. 3D printed (3DP) models of three human cadaveric temporal bones, previously submitted to CT scan, were created with the representation of a topographic bone thickness map and the sinus pathway on the outer surface. The 3DP model was used to detect the most suitable location for the BB. A 3DP transparent mask that faithfully reproduced the surface of both the temporal bone and the 3DP model was also developed to correctly transfer the designated BB area. The accuracy of the procedure was verified by CT scan: a radiological marker was used to evaluate the degree of correspondence of the transducer site between the 3DP model and the human temporal bone. The BB positioning was successfully performed on all human temporal bones, with no difficulties in finding the proper location of the transducer. A mean error of 0.13 mm was found when the transducer site of the 3DP model was compared to that of the human temporal bone. The employment of 3D printing technology in surgical planning of BB positioning showed feasible results. Further studies will be required to evaluate its clinical applicability.

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Many types of fully implantable hearing aids have been developed. Most of these devices are implanted behind the ear. To maintain the implanted device for a long period of time, a rechargeable battery and wireless power transmission are used. Because inductive coupling is the most renowned method for wireless power transmission, many types of fully implantable hearing aids are transcutaneously powered using inductively coupled coils. Some patients with an implantable hearing aid require a method for conveniently charging their hearing aid while they are resting or sleeping. To address this need, a wireless charging pillow has been developed that employs a circular array coil as one of its primary parts. In this device, all primary coils are simultaneously driven to maintain an effective charging area regardless of head motion. In this case, however, there may be a magnetic weak zone that cannot be charged at the specific secondary coil's location on the array coil. In this study, assuming that a maximum charging distance is 4 cm, a circular array coil-serving as a primary part of the charging pillow-was designed using finite element analysis. Based on experimental results, the proposed device can charge an implantable hearing aid without a magnetic weak zone within 4 cm of the perpendicular distance between the primary and secondary coils.

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The surgical procedure for Bonebridge implantation cannot be done in some cases without exposing the dura mater or sigmoid sinus. Surgical simulation technology can help to identify such difficulties prior to surgery and be used to clarify the optimal location and orientation of the device to be implanted. However, there has not been a simple strategy to drill the temporal bone at exactly the same location as that simulated on the computer. Based on our previous development of the surface template-assisted marker positioning (STAMP) method for performing image-guided otologic surgery, we recently developed a noninvasive guiding method, the BB-STAMP method, for performing image-guided Bonebridge implantation. Three patients underwent Bonebridge implantation at our surgical center during the years of 2013-2014. The authors in the simulation center supported the surgery using the BB-STAMP method. The time and effort required to prepare for the surgery were evaluated. In addition, a postoperative analysis was performed to assess the accuracy of placing the device in the planned location. The BB-STAMP method enabled the surgeon to precisely replicate the computer simulation in the real patient with submillimetric accuracy without complexity. Thus, the use of experienced and elaborative simulation coupled with the creation of a tailor-made three-dimensional template (BB-STAMP) enables surgeons to perform quick, precise and safe surgical procedures at distant institutions.

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The objective of this review is to remind the ENT community of the essential role of the French teams in the development and finalization of the multi-electrode cochlear implant (MCI), which has deliberately been neglected, and to repair the oblivion into which France was curiously cast at the end of the last century. It aims to underline significant scientific publications from the researchers who played key roles in the development of MCIs. In conclusion, the Parisian team of the ENT Lab in Saint Antoine Hospital in Paris can claim priority for its work in five regards. We were the first: (1) to plot in 1976 a frequency map of the whole length of three living human cochleas; (2) on September 22, 1976, to set up total cochlear implantation in a deaf adult male with eight electrodes; (3) on March 16, 1977, to apply for a patent for an implantable hearing aid in humans; (4) to describe sound signal processing (SSP) for a functional cochlear implant able to supply totally deaf patients with speech discrimination without the help of lip-reading; (5) in 1983, to experimentally demonstrate why it was necessary to place a cochlear implant as early as possible, in case of profound neonatal deafness. An injustice has occurred. These facts will be brought to the knowledge of the scientific community.

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The Vibrant Soundbridge is the world's most often implanted active middle ear implant or hearing aid. During the last few years, the device indications have expanded from sensorineural hearing loss to conductive and mixed hearing loss. Titanium couplers have led to improved contact of the floating mass transducer with the middle ear structures. The resulting hearing gain is satisfying for most patients, but so far, there is no clear audiologic advantage over conventional hearing aids. Currently, the indications are mainly related to intolerance of conventional hearing aids (eg, chronic otitis externa), severe mixed hearing loss with a destructed middle ear and certain medical diagnosis (eg, congenital atresia).

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This article discusses the Envoy Esteem implantable hearing system, a completely implantable hearing device. The device is indicated for patients older than 18 years with stable moderate to severe sensorineural hearing loss and good speech discrimination. The device is placed through an intact canal wall tympanomastoidectomy with a wide facial recess approach. The implant is typically activated at 6 to 8 weeks postoperatively and usually requires several adjustments for optimal performance. The sound processor/battery lasts 4.5 to 9.0 years and can be replaced through a minor outpatient procedure.

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Introduction: The complaints associated with the use of conventional amplifying hearing aids prompted research at several centers worldwide that ultimately led to the development of implantable devices for aural rehabilitation. Objectives: To review the history, indications, and surgical aspects of the implantable middle ear hearing devices. Data Synthesis Implantable hearing aids, such as the Vibrant Soundbridge system (Med-El Corporation, Innsbruck, Austria), the Maxum system (Ototronix LLC, Houston, Texas, United States), the fourth-generation of Carina prosthesis (Otologics LLC, Boulder, Colorado, United States), and the Esteem device (Envoy Medical Corporation - Minnesota, United States), have their own peculiarities on candidacy and surgical procedure. Conclusion: Implantable hearing aids, which are currently in the early stages of development, will unquestionably be the major drivers of advancement in otologic practice in the 21st century, improving the quality of life of an increasingly aged population, which will consequently require increased levels of hearing support...

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The round window (RW) membrane provides pressure relief when the cochlea is excited by sound. Here, we report measurements of cochlear function from guinea pigs when the cochlea was stimulated at acoustic frequencies by movements of a miniature magnet which partially occluded the RW. Maximum cochlear sensitivity, corresponding to subnanometre magnet displacements at neural thresholds, was observed for frequencies around 20 kHz, which is similar to that for acoustic stimulation. Neural response latencies to acoustic and RW stimulation were similar and taken to indicate that both means of stimulation resulted in the generation of conventional travelling waves along the cochlear partition. It was concluded that the relatively high impedance of the ossicles, as seen from the cochlea, enabled the region of the RW not occluded by the magnet, to act as a pressure shunt during RW stimulation. We propose that travelling waves, similar to those owing to acoustic far-field pressure changes, are driven by a jet-like, near-field component of a complex pressure field, which is generated by the magnetically vibrated RW. Outcomes of research described here are theoretical and practical design principles for the development of new types of hearing aids, which use near-field, RW excitation of the cochlea.

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Introduction The complaints associated with the use of conventional amplifying hearing aids prompted research at several centers worldwide that ultimately led to the development of implantable devices for aural rehabilitation. Objectives To review the history, indications, and surgical aspects of the implantable middle ear hearing devices. Data Synthesis Implantable hearing aids, such as the Vibrant Soundbridge system (Med-El Corporation, Innsbruck, Austria), the Maxum system (Ototronix LLC, Houston, Texas, United States), the fourth-generation of Carina prosthesis (Otologics LLC, Boulder, Colorado, United States), and the Esteem device (Envoy Medical Corporation - Minnesota, United States), have their own peculiarities on candidacy and surgical procedure. Conclusion Implantable hearing aids, which are currently in the early stages of development, will unquestionably be the major drivers of advancement in otologic practice in the 21st century, improving the quality of life of an increasingly aged population, which will consequently require increased levels of hearing support.

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Hearing aids are the principal means of auditory rehabilitation for patients with moderate to severe sensorineural hearing loss. Although technical improvements and modifications have improved the fidelity of conventional aids, hearing aids still have many limitations. Implantable hearing aids offer patients with hearing loss several potential advantages over conventional hearing aids. This presentation will highlight our first experience, the indications, the procedure, the advantages and the current status of totally implantable hearing aids.

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Malformations of the middle ear are classified as minor and major malformations. Minor malformations appear with regular external auditory canal, tympanic membrane and aerated middle ear space. The conducting hearing loss is due to fixation or interruption of the ossicular chain. The treatment is surgical, following the rules of ossiculoplasty and stapes surgery. In major malformations (congenital aural atresia) there is no external auditory canal and a deformed or missing pinna. The mastoid and the middle ear space may be underdevelopped, the ossicular chain is dysplastic. Surgical therapy is possible in patients with good aeration of the temporal bone, existing windows, a near normal positioned facial nerve and a mobile ossicular chain. Plastic and reconstructive surgery of the pinna should proceed the reconstruction of the external auditory canal and middle ear. In cases of good prognosis unilateral aural atresia can be approached already in childhood. In patients with high risk of surgical failure, bone anchored hearing aids are the treatment of choice. Recent reports of implantable hearing devices may be discussed as an alternative treatment for selected patients.