Semi-implantable Middle Ear Electromagnetic Hearing Device for Sensorineural Hearing Loss

1997 ◽  
Vol 76 (5) ◽  
pp. 333-341 ◽  
Author(s):  
Anthony J. Maniglia ◽  
Wen H. Ko ◽  
Steven L. Garverick ◽  
Hassan Abbass ◽  
Michael Kane ◽  
...  
Keyword(s):  
Hearing Loss ◽  
Sensorineural Hearing Loss ◽  
Middle Ear ◽  
Subjective Evaluation ◽  
The Body ◽  
Sensorineural Hearing ◽  
Rf Amplifier ◽  
Audio Amplifier ◽  
Receiving Antenna ◽  
Hearing Device

A semi-implantable middle ear electromagnetic hearing device (SIMEHD) is proposed for limited clinical trial in adult patients to evaluate the implantable hearing device for moderate to severe sensorineural hearing loss. Food and Drug Administration (FDA) investigational device exemption (IDE) approval has been granted (May 1996) for clinical trials. The implant unit has been evaluated acutely and chronically in animals (cats) with excellent results. Five cats undergoing chronic implantation were allowed to survive an average of 9.6 months, showing that the SIMEHD is biocompatible, functional and without untoward complications. All implant units recovered from the cats were functional, except for wire breakage of the internal antenna. A new antenna was redesigned for human implantation. The SIMEHD system consists of an external and internal unit. The external unit consists of a microphone, audio amplifier, modulator, radio frequency (RF) amplifier, antenna and battery. The internal unit is composed of a receiving antenna, hybrid electronic circuit, air core driving coil, and a target magnet cemented to the incus. All materials in contact with the body are biocompatible and expected to survive indefinitely. The implant unit is miniaturized and manufactured with existing fabrication technology by our industrial collaborator, Wilson Greatbatch, Ltd. The specific aims and major tasks of the proposed research are: a) to evaluate reliability, safety and efficacy of the SIMEHD system in a selected group of patients diagnosed with sensorineural hearing loss, due mainly to presbycusis or aging of the inner ear; and b) to obtain objective and subjective evaluation of audiologic and psychoacoustic performance as compared to the acoustic hearing aid. This paper describes the design, illustrates the actual device (newest prototype) and details the technique for surgical implantation in the attic and mastoid antrum in humans.

A Contactless Electromagnetic Implantable Middle Ear Device for Sensorineural Hearing Loss

1994 ◽  
Vol 73 (2) ◽  
pp. 78-90 ◽  
Author(s):  
Anthony J. Maniglia ◽  
Wen H. Ko ◽  
Mary Rosenbaum ◽  
Wei-Lin Zhu ◽  
John Werning ◽  
...  
Keyword(s):  
Hearing Loss ◽  
Solid State ◽  
Sensorineural Hearing Loss ◽  
Middle Ear ◽  
Animal Experiments ◽  
The Body ◽  
Sensorineural Hearing ◽  
Air Core ◽  
Hearing Device ◽  
Hybrid Circuit

Following basic science experiments, improvement of precision micromechanics and electronics design, and development of different prototypes, a contactless electromagnetic hearing device has been successfully implanted in cats (acute experiments). Chronic animal experiments using the cat as well as the rabbit are ongoing to test the components of the device. A highly efficient air core coil is used to vibrate a neodymium-iron-boron magnet cemented to the body of the incus. The parts of the system, including implanted electronics (hybrid circuit, solid state), are laser welded and hermetically sealed. The system allows for the generation of enough force which vibrates the magnet implanted on the incus. It would be suitable for the treatment of moderate to severe sensorineural hearing loss.

scholarly journals Design Study of a Round Window Piezoelectric Transducer for Active Middle Ear Implants

Sensors ◽  
2021 ◽  
Vol 21 (3) ◽  
pp. 946
Author(s):  
Dong Ho Shin
Keyword(s):  
Hearing Loss ◽  
Sensorineural Hearing Loss ◽  
Middle Ear ◽  
Piezoelectric Transducer ◽  
Round Window ◽  
Piezoelectric Element ◽  
Sensorineural Hearing ◽  
Flat Band ◽  
Middle Ear Implants ◽  
Output Characteristics

This report describes the design of a new piezoelectric transducer for round window (RW)-driven middle ear implants. The transducer consists of a piezoelectric element, gold-coated copper bellows, silicone elastomer (polydimethylsiloxane, PDMS), metal cylinder (tungsten), and titanium housing. The piezoelectric element is fixed to the titanium housing and mechanical resonance is generated by the interaction of the bellows, PDMS, and tungsten cylinder. The dimensions of PDMS and the tungsten cylinder with output characteristics suitable for compensation of sensorineural hearing loss were derived by mechanical vibrational analysis (equivalent mechanical model and finite element analysis (FEA)). Based on the results of FEA, the RW piezoelectric transducer was implemented, and bench tests were performed under no-load conditions to confirm the output characteristics. The transducer generates an average displacement of 219.6 nm in the flat band (0.1–1 kHz); the resonance frequency is 2.3 kHz. To evaluate the output characteristics, the response was compared to that of an earlier transducer. When driven by the same voltage (6 Vp), the flat band displacement averaged 30 nm larger than that of the other transducer, and no anti-resonance was noted. Therefore, we expect that the new transducer can serve as an output device for hearing aids, and that it will improve speech recognition and treat high-frequency sensorineural hearing loss more effectively.

Otologics Fully Implantable Hearing Device Phase II Results

2008 ◽  
Vol 139 (2_suppl) ◽  
pp. P57-P57
Author(s):  
Drew M Horlbeck ◽  
Herman A Jenkins ◽  
Ben J Balough ◽  
Michael E Hoffer
Keyword(s):  
Hearing Loss ◽  
Sensorineural Hearing Loss ◽  
Phase Ii ◽  
Hearing Aids ◽  
Repeated Measures ◽  
Pure Tone ◽  
Sound Field ◽  
Sensorineural Hearing ◽  
Significant Difference ◽  
Hearing Device

Objective The efficacy of the Otologics Fully Implantable Hearing Device (MET) was assessed in adult patients with bilateral moderate to severe sensorineural hearing loss. Methods Surgical insertion of this totally implanted system was identical to the Phase I study. A repeated-measures within-subjects design assessed aided sound field thresholds and speech performances with the subject's own, appropriately fit, walk-in hearing aid(s) and the Otologics Fully Implantable Hearing Device. Results Six- and 12-month Phase II data will be presented. Ten patients were implanted and activated as part Phase II clinical trial. Three patients were lost to long term follow-up due to two coil failures and one ossicular abnormality preventing proper device placement. No significant differences between preoperative (AC = 59 dB, BC = 55 dB) and postoperative (AC = 61 dB, BC = 54 dB) unaided pure tone averages were noted (p < 0.05). Pure tone average implant aided thresholds (41 dB) were equivalent to that of walk-in-aided (37 dB) condition with no significant difference (p < 0.05) between patients’ walk-in-aided individual frequency thresholds and implant-aided thresholds. Word recognition scores and hearing in noise scores were similar between the walk-in-aided and for the implant-aided condition. Patient benefit scales will be presented at all end points. Conclusions Results of the Otologics MET Fully Implantable Hearing Device Phase II trial provide evidence that this fully implantable device is a viable alternative to currently available hearing aids in patients with sensorineural hearing loss.

A new semi-implantable middle ear implant for sensorineural hearing loss: three-years follow-up in a pilot patient’s group

2017 ◽  
Vol 138 (1) ◽  
pp. 31-35 ◽  
Author(s):  
Maurizio Barbara ◽  
Luigi Volpini ◽  
Chiara Filippi ◽  
Francesca Atturo ◽  
Simonetta Monini
Keyword(s):  
Hearing Loss ◽  
Sensorineural Hearing Loss ◽  
Middle Ear ◽  
Sensorineural Hearing ◽  
Middle Ear Implant

scholarly journals Cisplatin Ototoxicity: Examination of the Impact of Dosing, Infusion Times, and Schedules In Pediatric Cancer Patients

2021 ◽  
Vol 11 ◽  
Author(s):  
Miranda L. Camet ◽  
Anne Spence ◽  
Susan S. Hayashi ◽  
Ningying Wu ◽  
Jennifer Henry ◽  
...  
Keyword(s):  
Risk Factors ◽  
Hearing Loss ◽  
Sensorineural Hearing Loss ◽  
Model Building ◽  
Significant Risk ◽  
The Body ◽  
Sensorineural Hearing ◽  
Cycle Number ◽  
Pediatric Cancer Patients ◽  
The Impact

BackgroundSensorineural hearing loss is a well-known side effect of cisplatin (CDDP). There is limited research on the effect of dosing, infusion times, and schedules of cisplatin administration and their impact on hearing loss.MethodsA retrospective review of 993 pediatric patients’ medical and audiological charts from August 1990 to March 2015 was conducted using stringent inclusion criteria to characterize patients with hearing loss. 248 of these patients received CDDP. Of these, 216 patients had sufficient CDDP infusion data to assess for sensorineural hearing loss attributable to CDDP and its associated risk factors. Chart reviews were performed to extract clinical data including CDDP dosing information. Demographic and clinical characteristics were summarized by descriptive statistics, and univariate and multivariate logistic regressions were performed to examine the relationship between hearing loss and specific parameters of cisplatin administration (amount infused per dose, prescribed infusion time, total number of doses, number of doses per cycle, number of cycles, cumulative cisplatin exposure). Stepwise variable selection procedure was performed in the multivariate model building to extract the best subset of risk factors for the prediction of hearing loss and worsening ototoxicity grade using an established ototoxicity grading scale from the International Society of Pediatric Oncology (SIOP).ResultsA total of 153 patients with complete medical and audiologic data were evaluable for analysis. Hearing loss was identified in 72.6% of the patients. Multivariate analysis revealed that age [OR=0.90 (0.84-0.97), p-value=0.0086], radiation to any part of the body, [OR=3.20 (1.29-7.93), p-value=0.012], amount infused per dose (mg/m2) [OR=1.018 (1.002-1.033), p-value=0.029], and cumulative cisplatin exposure (mg/m 2) [OR=1.004 (1-1.008), p-value=0.027] were associated with hearing loss. Similar associations were also found between these risk factors and worsening SIOP grade.ConclusionIn one of the largest studies examining the influence of CDDP dosing and schedules on hearing loss, we found the amount of CDDP infused per dose is a significant risk factor. Considerations in designing regimens that reduce the amount of CDDP infused per dose may reduce the risk of hearing loss. Randomized prospective trials are needed.

Effects of Platelet Activating Factor on the Tubotympanic Mucosa and Inner Ear in the Guinea Pig

1998 ◽  
Vol 107 (10) ◽  
pp. 876-884 ◽  
Author(s):  
Yoshiharu Ohno ◽  
Yoshihiro Ohashi ◽  
Hideki Okamoto ◽  
Yoshikazu Sugiura ◽  
Yoshiaki Nakai
Keyword(s):  
Hearing Loss ◽  
Sensorineural Hearing Loss ◽  
Inner Ear ◽  
Otitis Media ◽  
Middle Ear ◽  
Otitis Media With Effusion ◽  
Platelet Activating Factor ◽  
Sensorineural Hearing ◽  
Ciliary Activity ◽  
Middle Ear Mucosa

The effect of platelet activating factor (PAF) was studied to elucidate its role in the pathogenesis of otitis media and sensorineural hearing loss. The PAF alone did not induce a reduction of ciliary activity of the cultured middle ear mucosa. However, a dose-dependent decrease in ciliary activity was observed in the presence of the medium containing both PAF and macrophages. Intravenous injection of PAF did not induce dysfunction of the mucociliary system or morphologic changes of epithelium in the tubotympanum, but cytoplasmic vacuolization and ballooning were observed in the inner ear within 1 hour after injection of PAF. In contrast, intratympanic injection of PAF induced mucociliary dysfunction and some pathologic changes in the tubotympanum. Intratympanic inoculation of PAF induced no pathologic findings in the inner ear. These results suggest that PAF is at least partially involved in the pathogenesis of certain middle ear diseases such as otitis media with effusion. Additionally, PAF might be involved in the pathogenesis of some types of unexplained sensorineural hearing loss.

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