Seven-Year Revision Rates for Cochlear Implants in Pediatric and Adult Populations of an Integrated Healthcare System.

OBJECTIVE: We assessed three cochlear implant (CI) suppliers: Advanced Bionics, Cochlear Limited, and MED-EL, for implant revision requiring reoperation after CI placement. STUDY DESIGN: Retrospective cohort study of integrated-health-system database between 2010 and 2021. Separate models were created for pediatric (age <18) and adult (age ≥18) cohorts. PATIENTS: Pediatric (age <18) and adult (age ≥18) patients undergoing cochlear implantation within our integrated healthcare system. MAIN OUTCOME MEASURE: Revision after CI placement. Cox proportional hazard regression was used to evaluate revision risk and adjust for confounding factors. Hazard ratios (HRs) and 95% confidence intervals (CIs) are presented. RESULTS: A total of 2,347 patients underwent a primary CI placement, and Cochlear Limited was most implanted (51.5%), followed by Advanced Bionics (35.2%) and MED-EL (13.3%). In the pediatric cohort, the 7-year crude revision rate was 10.9% for Advanced Bionics and 4.8% for Cochlear Limited, whereas MED-EL had insufficient cases. In adults, the rates were 9.1%, 4.5%, and 3.3% for Advanced Bionics, MED-EL, and Cochlear Limited, respectively. After 2 years of postoperative follow-up, Advanced Bionics had a significantly higher revision risk (HR = 8.25, 95% CI = 2.91-23.46); MED-EL had no difference (HR = 2.07, 95% CI = 0.46-9.25). CONCLUSION: We found an increased revision risk after 2 years of follow-up for adults with Advanced Bionics CI devices. Although we found no statistical difference between manufacturers in the pediatric cohort, after 2 years of follow-up, there were increasing trends in the revision probability for Advanced Bionics. Further research may determine whether patients are better suited for some CI devices.

Humanitarian otologic missions: long-term surgical results.

OBJECTIVE: The purpose of this study was to determine the efficacy of treating chronic ear disease by performing a single surgical intervention in the austere environment of a developing nation. SUBJECTS AND METHODS: Data were collected from retrospective chart reviews on 121 patients who underwent surgical treatment of chronic ear disease during humanitarian surgical missions in South and Central America. Surgical outcomes and clinical course were assessed at 10 to 12 months after the initial surgery. RESULTS: A total of 117 patients were included in the study. Follow-up records were available for 75 patients (64%). A total of 20 surgeries were performed for dry perforations (group 1), 30 for chronically draining ears (group 2), and 25 for cholesteatomas (group 3). Surgical success was determined as 60 percent, 74 percent, and 92 percent for groups 1, 2, and 3, respectively. CONCLUSIONS: Surgical results during international otologic outreach missions to developing nations fall within the results expected in developed nations.

Blunt and blast head trauma: different entities.

Mild traumatic brain injury (mTBI) caused by blast-related and blunt head trauma is frequently encountered in clinical practice. Understanding the nuances between these two distinct types of injury leads to a more focused approach by clinicians to develop better treatment strategies for patients. In this study, we evaluated two separate cohorts of mTBI patients to ascertain whether any difference exists in vestibular-ocular reflex (VOR) testing (n = 55 enrolled patients: 34 blunt, 21 blast) and vestibular-spinal reflex (VSR) testing (n = 72 enrolled patients: 33 blunt, 39 blast). The VOR group displayed a preponderance of patients with blunt mTBI, demonstrating normal to high-frequency phase lag on rotational chair testing, whereas patients experiencing mTBI from blast-related causes revealed a trend toward low-frequency phase lag on evaluation. The VSR cohort showed that patients with posttraumatic migraine-associated dizziness tended to test higher on posturography. However, an indepth look at the total patient population in this second cohort reveals that a higher percentage of blast-exposed patients exhibited a significantly increased latency on motor control testing as compared to patients with blunt head injury (p < .02). These experiments identify a distinct difference between blunt-injury and blast-injury mTBI patients and provide evidence that treatment strategies should be individualized on the basis of each mechanism of injury.

Otologics fully implantable hearing system: Phase I trial 1-year results.

OBJECTIVE: To assess the safety of the Otologics fully implantable hearing system after 1 year of use in a Phase I clinical trial. STUDY DESIGN: Repeated-measures within-subjects design. SETTING: Procedures were performed in a variety of facilities, including a university, military, and private hospital's ambulatory surgical center and outpatient clinical audiologic test facilities. PATIENTS: Adult patients with bilateral moderate to severe sensorineural hearing loss. INTERVENTION(S): Surgical insertion of this prosthesis included an atticotomy to expose the incus, securing the transducer to the mastoid bone, attaching the transducer tip to the incus via insertion into a laser-drilled hole, and postauricular implantation of the microphone/battery/electronics capsule. MAIN OUTCOME MEASURE(S): Subjective patient benefit, aided sound field thresholds, and speech discrimination with the subject's own, appropriately fit, walk-in hearing aid(s) and the prosthesis were assessed. RESULTS: There were no pre-post-implant differences noted for bone conduction: slight differences were noted in the pre-post-implant air conduction results (p < 0.05). These differences were attributed to the healing process and reversed to almost preimplant assessment levels by the third-month evaluation. Pure-tone averages and monaural word recognition scores were slightly better for the walk-in-aided condition (p < 0.05), whereas the patient benefit scales favored the postoperative implant-aided conditions.Adverse effects of the implant were encountered on 14 occasions after the implantation of the 20 subjects. With the exception of partial device extrusions (that occurred later), all were rectified by the time of initial activation. At the 12-month data collection point, problems that had been encountered by subjects included 1) partial device extrusion (3 subjects), necessitating explantation in 2; 2) loss of external communication (2 subjects), resulting in 1 explantation; and 3) increased charging times beyond 1.5 hours (7), resulting in 3 explantations and 2 patients not using their device while awaiting explantation. CONCLUSION: Phase I trial results provide evidence that this fully implantable device can provide sound amplification to sensorineural hearing loss patients, with performance results similar to the patients' walk-in hearing aids.

Influence of ultrahigh-frequency hearing thresholds on distortion-product otoacoustic emission levels at conventional frequencies.

This study examined the association between ultrahigh-frequency (UHF) hearing sensitivity and distortion-product otoacoustic emission (DPOAE) levels at conventional frequencies. Behavioral thresholds were measured from 2 through 16 kHz, and DPOAE levels were measured at discrete f2 frequencies between 2 through 8 kHz in 553 young normal-hearing adult male participants. A DPOAE frequency sweep was measured with primary stimulus levels of L1/L2 = 65/55 dB SPL and an f2/f1 of 1.2. Significant negative correlations, although weak, were found between UHF behavioral thresholds and DPOAE levels. As UHF behavioral thresholds worsened, DPOAE levels decreased at all frequencies. When the data were categorized into two groups, "better" and "worse" UHF behavioral thresholds, significant differences were apparent between the two groups for DPOAEs. Additionally, those with better UHF thresholds had better conventional thresholds compared to those in the worse UHF threshold group. The results of this age-restricted, large-sample-size study confirm and augment findings from earlier studies demonstrating that UHF hearing sensitivity has some influence on DPOAE measures at frequencies from 2 through 8 kHz with moderate stimulus levels. However, because those with better UHF thresholds also had better conventional thresholds and the significant correlations found were weak, this work supports the importance of UHF hearing testing in conjunction with otoacoustic emission measures to identify basal cochlear insults not evident from behavioral testing at conventional frequencies.

NAC for noise: from the bench top to the clinic.

Noise-induced hearing loss (NIHL) is an important etiology of deafness worldwide. Hearing conservation programs are in place and have reduced the prevalence of NIHL, but this disorder is still far too common. Occupational and recreational pursuits expose people to loud noise and ten million persons in the US have some degree of noise-induced hearing impairment. It is estimated that 50 million in the US and 600 million people worldwide are exposed to noise hazards occupationally. Noise deafness is still an important and frequent cause of battlefield injury in the US military. A mainstay of hearing conservation programs is personal mechanical hearing protection devices which are helpful but have inherent limitations. Research has shown that oxidative stress plays an important role in noise-induced cochlear injury resulting in the discovery that a number of antioxidant and cell death inhibiting compounds can ameliorate deafness associated with acoustic trauma. This article reviews one such compound, N-acetylcysteine (NAC), in terms of its efficacy in reducing hearing loss in a variety of animal models of acute acoustic trauma and hypothesizes what its therapeutic mechanisms of action might be based on the known actions of NAC. Early clinical trials with NAC are mentioned.

U.S. Phase I preliminary results of use of the Otologics MET Fully-Implantable Ossicular Stimulator.

OBJECTIVES: The safety of the Otologics Fully-Implantable MET Ossicular Stimulator was assessed in adult patients with bilateral moderate to severe sensorineural hearing loss. METHODS: Surgical implantation of the ossicular stimulator was performed. A repeated-measure, within-subjects design assessed safety and aided sound field thresholds and speech performances with the subject's own, appropriately fitted, walk-in hearing aid(s) and the Otologics Fully-Implantable MET Ossicular Stimulator. RESULTS: Twenty patients were implanted and activated as part of the Phase I clinical trial. Results demonstrated 10-20 dB of functional gain across audiometric frequencies. Pure tone averages and monaural word recognition scores were slightly better for the walk-in-aided condition, while patient benefit scales favored the postoperative implant-aided conditions. CONCLUSION/SIGNIFICANCE: Although monaural word scores and aided thresholds favored the walk-in-aided condition, preliminary results indicate that the Otologics MET Fully-Implantable Ossicular Stimulator is an alternative to currently available hearing aids in patients with sensorineural hearing loss.

Distribution of PLGA nanoparticles in chinchilla cochleae.

OBJECTIVES: To study the distribution of polylactic/glycolic acid-encapsulated iron oxide nanoparticles (PLGA-NPs) in chinchilla cochleae after application on the round window membrane (RWM). STUDY DESIGN AND SETTING: Six chinchillas (12 ears) were equally divided into controls (no treatments) and experimentals (PLGA-NP with or without magnetic exposure). After 40 minutes of PLGA-NP placement on the RWM, perilymph was withdrawn from the scala tympani. The RWM and cochleae were fixed with 2.5% glutaraldehyde and processed for transmission electron microscopy. RESULTS: Nanoparticles were found in cochleae with or without exposure to magnet forces appearing in the RWM, perilymph, endolymph, and multiple locations in the organ of Corti. Electron energy loss spectroscopy confirmed iron elements in nanoparticles. CONCLUSION: The nanoparticles were distributed throughout the inner ear after application on the chinchilla RWM, with and without magnetic forces. SIGNIFICANCE: PLGA-NP applied to the RWM may have potential for sustained therapy to the inner ear.

Risk factors for distortion product otoacoustic emissions in young men with normal hearing.

The purpose of this study was to evaluate the possible effects of risk factors on distortion product otoacoustic emissions (DPOAEs) in young adult men with normal hearing. Four hundred thirty-six United States Marine recruit men (mean age = 19.2 years +/- 1.8 years; age range = 17-29 years) participated in this study. Questionnaires were given to each recruit to obtain demographic data and history of noise exposure, solvent exposure, smoking history, and hearing-related histories. Otoscopy, tympanometry, pure-tone air-conduction audiometry (2.0-8.0 kHz) and DPOAEs (2.3-8.0 kHz) were measured. DPOAE levels were lower in Not Hispanic or Latino recruits, in heavy smokers, in recruits who reported loud live music exposure and ringing in their ears after noise exposure. These differences were not statistically significant at all frequencies. Recruits with multiple risk factors had the lowest DPOAEs as compared to recruits with fewer, or no, risk factors; these differences were not statistically significant. Obtaining risk factor data as part of an audiometric evaluation is important even though the individual may have normal hearing.

Posttraumatic balance disorders.

Head trauma is being more frequently recognized as a causative agent in balance disorders. Most of the published literature examining traumatic brain injury (TBI) after head trauma has focused on short-term prognostic indicators and neurocognitive disorders. Few data are available to guide those individuals who see patients with balance disorders secondary to TBI. Our group has previously examined balance disorders after mild head trauma. In this study, we study all classes of head trauma. We provide a classification system that is useful in the diagnosis and management of balance disorders after head trauma and we examine treatment outcomes. As dizziness is one of the most common outcomes of TBI, it is essential that those who study and treat dizziness be familiar with this subject.

Delivery of drugs to the inner ear.

PURPOSE OF REVIEW: Inner ear delivery of medicines has been a rapidly expanding field in otolaryngology. This technique provides a minimally invasive way of managing a number of otolaryngologic diagnoses and promises to provide a therapeutic option for previously untreatable disorders. The purpose of this review is to examine the literature that has been published recently (since January of 2005) in this field and to explore how this new literature has impacted on current practices. RECENT FINDINGS: While there was a significant volume of work done in this area from 1995 to 2004, publication in this area has slowed considerably. The literature focuses on two areas: the treatment of Ménière's disease with gentamicin and the treatment of sudden sensorineural hearing loss with steroids. The most promising area in this field, which is the development of new medicines to treat a variety of disorders, has not progressed over the last 2 years. SUMMARY: Recent peer-reviewed publications have not had a significant impact on the transtympanic treatment of Ménière's disease or sudden sensorineural hearing loss. We will review the current practices in these two areas, discuss the newest developments and examine how we can progress the field over the next several years.

Review of pharmacological therapy for tinnitus.

This article provides a review of studies investigating the pharmacological treatment of tinnitus. Tinnitus continues to be a significant and costly health problem without a uniformly accepted treatment. A wide variety of studies exploring prescription, supplement, and vitamin therapies are assessed for efficacy of treatment and for establishing consistencies in symptom definition, assessment, and outcome measures. This review reveals no compelling evidence suggesting the efficacy of any pharmacological agent in the treatment of tinnitus. Analysis of prior investigations provides insight to appropriate methods for future work, which are outlined.

Single-staged resections and 3D reconstructions of the nasion, glabella, medial orbital wall, and frontal sinus and bone: Long-term outcome and review of the literature.

BACKGROUND: Aesthetic facial appearance following neurosurgical ablation of frontal fossa tumors is a primary concern for patients and neurosurgeons alike. Craniofacial reconstruction procedures have drastically evolved since the development of three-dimensional computed tomography imaging and computer-assisted programming. Traditionally, two-stage approaches for resection and reconstruction were used; however, these two-stage approaches have many complications including cerebrospinal fluid leaks, necrosis, and pneumocephalus. CASE DESCRIPTION: We present two successful cases of single-stage osteoma resection and craniofacial reconstruction in a 26-year-old female and 65-year-old male. The biopolymer implants were preselected and contoured based on imaging prior to surgery. The ideal selection of appropriate flaps for reconstruction was imperative. The flaps were well vascularized and included a pedicle for easy translocation. Using a titanium mesh biopolymer implant for reconstruction in conjunction with a forehead flap proved advantageous, and the benefits of single-stage approaches were apparent. The patients recovered quickly after the surgery with complete resection of the osteoma and good aesthetic appearance. The flap adhered to the biopolymer implant, and the cosmetic appearance years after surgery remained decent. The gap between the bone and implant was less than 2 mm. The patients are highly satisfied with the symmetrical appearance of the reconstruction. CONCLUSIONS: Advances in technology are allowing neurosurgeons unprecedented opportunities to design complex yet feasible single-stage craniofacial reconstructions that improve a patient's quality of life by enhancing facial contours, aesthetics, and symmetry.

The role of vestibular rehabilitation in the treatment of Meniere's disease.

OBJECTIVE: To study the role of vestibular rehabilitation is treating patients with Meniere's disease. METHODS: We examined all Meniere's patients presenting to our tertiary care specialized vestibular clinic during a 1-year period. All patients underwent a standardized history and physical examination, a complete auditory-vestibular test battery, and a set of physical therapy tools to measure balance function. RESULTS: A subset of patients suffered from disequilibrium or unsteadiness between attacks. Once the acute fluctuating symptoms of Meniere's were controlled in this group of individuals, all of them underwent vestibular physical therapy and demonstrated significant improvement in balance function on both objective and self-report tests. CONCLUSIONS: Due to the fluctuating nature of the disorder, vestibular physical therapy has had a limited role in the treatment of Meniere's disease. In general, rehabilitation has been used only as a postoperative treatment for the acute vertigo seen after vestibular neurectomy or labyrinthectomy. This is the first report advocating the role of vestibular physical therapy in a group of patients receiving medical therapy of intraear medicines (other that gentamicin).

Efficacy and safety of N-acetylcysteine in prevention of noise induced hearing loss: a randomized clinical trial.

Despite a robust hearing conservation program, military personnel continue to be at high risk for noise induced hearing loss (NIHL). For more than a decade, a number of laboratories have investigated the use of antioxidants as a safe and effective adjunct to hearing conservation programs. Of the antioxidants that have been investigated, N-acetylcysteine (NAC) has consistently reduced permanent NIHL in the laboratory, but its clinical efficacy is still controversial. This study provides a prospective, randomized, double-blinded, placebo-controlled clinical trial investigating the safety profile and the efficacy of NAC to prevent hearing loss in a military population after weapons training. Of the 566 total study subjects, 277 received NAC while 289 were given placebo. The null hypothesis for the rate of STS was not rejected based on the measured results. While no significant differences were found for the primary outcome, rate of threshold shifts, the right ear threshold shift rate difference did approach significance (p = 0.0562). No significant difference was found in the second primary outcome, percentage of subjects experiencing an adverse event between placebo and NAC groups (26.7% and 27.4%, respectively, p = 0.4465). Results for the secondary outcome, STS rate in the trigger hand ear, did show a significant difference (34.98% for placebo-treated, 27.14% for NAC-treated, p-value = 0.0288). Additionally, post-hoc analysis showed significant differences in threshold shift rates when handedness was taken into account. While the secondary outcomes and post-hoc analysis suggest that NAC treatment is superior to the placebo, the present study design failed to confirm this. The lack of significant differences in overall hearing loss between the treatment and placebo groups may be due to a number of factors, including suboptimal dosing, premature post-exposure audiograms, or differences in risk between ears or subjects. Based on secondary outcomes and post hoc analyses however, further studies seem warranted and are needed to clarify dose response and the factors that may have played a role in the observed results.

Characterizing and treating dizziness after mild head trauma.

OBJECTIVE: The objectives of this study were to characterize patterns of dizziness seen after mild head trauma and to examine the diagnosis and treatment of this disorder. STUDY DESIGN: Prospective patient registry. SETTING: Tertiary referral center. PATIENTS: Fifty-eight cases of active duty and retired military personnel who sustained mild head trauma and had resultant dizziness. INTERVENTIONS: Vestibular evaluation, characterization by group, and treatment. MAIN OUTCOME MEASURES: Outcome measures include characterization of diagnosis types, patient distribution by diagnosis type, and patient outcome. RESULTS: Individuals suffering from dizziness after mild head injury were divided into three diagnostic groups. Forty-one percent of the individuals suffered from posttraumatic vestibular migraines, 28% of the individuals had posttraumatic positional vertigo, and 19% of the individuals were classified as posttraumatic spatial disorientation. The remaining 12% of the patients could not be characterized. The positional group had objective physical examination findings, which cleared with treatment in all cases. The migraine group of patients and the disorientation group of patients had distinct abnormalities of the vestibulo-ocular reflex (VOR) and the vestibulo-spinal reflex (VSR). Eighty-four percent of the migraine group demonstrated an improvement of these test results as compared with 27% of the disorientation group. Mean time to return to work was less than 1 week for the positional group, 3.8 weeks for the migraine group, and greater than 3 months for the disorientation group. CONCLUSIONS: Using our patient registry of individuals suffering from dizziness after mild head trauma, we were able to characterize the majority of these cases into one of three more specific diagnostic groups. We present diagnostic criteria, suggested treatment guidelines, and our prognostic data.

Sustained-release devices in inner ear medical therapy.

Inner ear medical therapy has been gaining increasing popularity during the last 2 decades. Despite the increased use of this therapy,basic questions regarding this type of treatment have not been answered. The authors have used a variety of sustained-release devices in the laboratory to begin to answer some of these basic questions. This article discusses the results of this work and the application and use of sustained-release devices in patients.

Sustained-release delivery of leupeptin in the chinchilla: hearing results.

Transtympanic medical therapy is becoming an increasingly popular modality for the treatment of "inner-ear disorders." While investigators continue to examine the best dosing paradigms for gentamicin in the treatment of Ménière's disease and for steroids in the treatment of hearing loss, they have also begun to focus on the use of other agents. In particular, transtympanic therapy has been advocated as a plausible route for the treatment of tinnitus. Transtympanic therapy for tinnitus is not new, and a number of groups have reported success in the past. Despite this success, a number of laboratories have been focusing on newer agents that might yield higher success rates in the treatment of tinnitus and other inner-ear disorders. Many of these agents could have systemic side effects when delivered in high enough doses; therefore, they are ideal candidates for transtympanic administration. The goal of this study is to begin to define the effects of one of these agents--leupeptin, a calpain antagonist--on the normal inner ear of an animal model. In this investigation, we demonstrate the effects of sustained-release delivery of leupeptin (2.5 micrograms/ml) on the hearing of chinchillas. The medicine produced no hearing loss at the early time points but did produce some hearing loss at later time points. We discuss these results and begin to outline the next steps in the investigation of this agent.

Management of the incus body in ossiculoplasty.

OBJECTIVE: (1) Evaluate the sound transfer impact of removal of the incus body in ossicular chain reconstruction (OCR) using an incus strut prosthesis. (2) Provide basic science data to assist clinical decision making in ossiculoplasty. STUDY DESIGN: Basic science. SETTING: Cadaveric temporal bone research laboratory. SUBJECTS AND METHODS: Ossicular chain reconstruction with an incus strut prosthesis was performed on 7 human temporal bones with and without the incus body. The difference in round window membrane (RWM) peak-to-peak displacements (90-dB sound pressure level, 250-8000 Hz) using single-point laser Doppler vibrometry (LDV) was compared with observed baseline, intact ossicular chain values. RESULTS: Comparing OCR using an incus strut prosthesis to an intact ossicular chain across all 7 temporal bones, the largest differences in RWM velocity occurred at 1011 and 2011 Hz. With increasing frequencies, RWM velocities of the OCR approached the intact ossicular chain. Using a Wilcoxon rank-sum test comparing the ossicular chain with and without the incus body showed no statistically significant difference across all frequencies (P = .925). Removing the incus body resulted in improved median RWM velocity (× 10(-2) mm/s) by 0.6 at 1011 Hz and a decrease of 0.6 at 2011 Hz. A rank-sum test to evaluate the difference at 1011 and 2011 Hz did not demonstrate statistical significance. CONCLUSION: Removal of the incus body in OCR using an incus strut prosthesis did not significantly change sound transfer function of the middle ear relative to its preservation. Our data suggest the impact of the retained mass in OCR to be minimal.

Effects of tympanomeatal blunting on sound transfer function.

OBJECTIVE: (1) To measure the peak-to-peak displacement of the round window membrane (RWM) prior to blunting procedure. (2) To evaluate the impact of blunting the anterior tympanomeatal angle (ATA) on middle ear sound transfer function. STUDY DESIGN: Basic science study. Setting. Cadaveric temporal bone research laboratory. SUBJECTS AND METHODS: Six fresh human temporal bones were prepared using a mastoidectomy and facial recess approach. Baseline RWM peak-to-peak displacements were obtained by single-point laser Doppler vibrometry (LDV) at 90-dB sound pressure level over a spectrum of 250 to 8000 Hz. Temporalis muscle was harvested and then fashioned into a graft for each temporal bone, mimicking ATA blunting. RWM displacement responses with the blunted ATA were measured using the LDV to judge the impact on middle ear transfer function. RESULTS: For each of the 6 temporal bones, the average displacement decreased across all sound frequencies with the ATA blunting when compared with baseline (no blunting). Baseline velocity measurements for all sound signals averaged 4.5 × 10(-3) ± 1.892 × 10(-3) (mean ± SEM) mm/s, while measurements averaged 2.2 ± 6.62 × 10(-4) mm/s with blunting of the ATA (P < .001). This amounted to a 52% decrease in velocity of the RWM following blunting of the ATA. CONCLUSION: Blunting of the ATA decreases the sound transfer function of the tympanic membrane and middle ear. Prevention of blunting at the ATA during tympanoplasty should be emphasized.