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Significant hearing loss among Americans is usually rehabilitated with the use of conventional hearing aids. Hearing aids have evolved significantly and become advanced over time. Although more advanced and beneficial they do not enjoy universal acceptance in the hearing impaired population. Implantable hearing systems have been developed to overcome the limitations of traditional hearing aids and provide the user with extra benefits. The fully implantable ossicular stimulator is one system currently under clinical investigation. The implantation technique of this device is presented as a new approach to the rehabilitation of patients with sensorineural hearing loss.

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.

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.

Objectives/Hypothesis: Transtympanic electrocochleography (t-ECOG) is a sensitive diagnostic instrument used for Meniere's disease. It is sensitive by virtue of the recording electrode's position on the promontory of the cochlea where the signals are generated. There is concern about the invasive nature of t-ECOG in comparison to extratympanic recording techniques. The purpose of this study was to examine the safety issues, complications, and patient experience with t-ECOG. Study Design: Observational study utilizing retrospective chart review and patient survey. Methods: The medical records of 205 patients who underwent t-ECOG were reviewed for complications. Complications included persistent tympanic membrane perforation, hearing loss, otitis media, otitis externa, ear canal injury, hemotympanum, and pain. An additional 36 patients undergoing t-ECOG were surveyed on subjective measures such as pain during topical anesthesia of the tympanic membrane, during transtympanic placement of the needle electrode, and during the test procedure and overall experience with t-ECOG. Results: There was one case of a nonhealed, persistent perforation in the setting of acute otitis media directly as a result of t-ECOG. Two patients developed otitis media, and three patients had ear pain for up to 5 days. All 36 patients felt the procedure to be tolerable with minimal discomfort. Conclusions: Transtympanic electrocochleography may be performed with good patient acceptance and infrequent complications.

Tinnitus is a common symptom encountered by otolaryngologists. Pulsatile tinnitus is rare and can present a diagnostic challenge. Establishing a diagnosis is important, because pulsatile tinnitus may indicate serious intracranial or extracranial disease. A unique case of pulsatile tinnitus caused by cervical artery dissection is presented, along with the differential diagnosis and treatment.

Objective: To determine the degree of bone resorption and stability of 3-cm, full-thickness canine mandibular defects reconstructed with recombinant human bone morphogenetic protein 2 (rhBMP-2) and a bioerodible particle carrier followed for 30 months after reconstruction. Study Design: Nine dogs, divided into three groups, underwent reconstruction of surgically created 3-cm, full-thickness defects of the body of the mandible. Methods: Mandibular reconstruction was performed via a combined intraoral and extraoral approach. Using standard plating techniques, a unilateral full-thickness, 3-cm defect was created in the body of the mandible. After stabilizing the defects with titanium reconstruction plates, test implants composed of rhBMP-2 and poly(lactide-co-glycolide) bioerodible particles were placed in the mandibular defects of six animals. Reconstruction plates were removed from test animals at 10 weeks. Three short-term test animals were sacrificed 3 months after reconstruction. Three long-term test animals were sacrificed 30 months after reconstruction to determine the degree of resorption and long-term stability of the rhBMP-2-induced bone. Control implants (carrier without rhBMP-2) were used in three animals and were sacrificed at 3 months. At 9 months, long-term animals were advanced to a solid diet. Masticatory function and body weight were monitored periodically to assess diet tolerance. Roentgenographic photodensitometry was performed on serial dental roentgenograms of the reconstructed segments to determine bone density and the degree of bone resorption over 30 months. After sacrifice, reconstructed segments were harvested and embedded in plastic for histological analysis and histomorphometry to determine the percentage of the defect replaced by mineralized bone (area density) and degree of resorption from 3 to 30 months after reconstruction. The main outcome measures were bone density and bone height determined from serial roentgenograms and percentage of the reconstructed segment replaced by mineralized bone (area density) determined from histomorphometry. Results: Control animals without rhBMP-2 showed no evidence of bone formation across the defect. Histological examination revealed good bone formation in two of three of the short-term test animals with a mean area density of 41.0%. The long-term test animals treated with rhBMP-2 demonstrated good bone formation that was comparable to that of normal host bone by 3 months. The roentgenographic photodensity measurements stabilized at 5 months without evidence of persistent bone resorption. The height of the reconstructed segment (rhBMP-2-induced bone) initially decreased, then stabilized by 11 months after reconstruction with no indication of resorption or failure. Histological examination of the long-term test animals revealed good bone formation across the mandibular defects. However, there were localized areas of thinning of the cortical bone as compared with the short-term test animals sacrificed at 3 months. Histological examination verified the loss of height of the bone in the reconstructed segments. The area density (mean) of the long-term test animals was 56.5%. Despite the decrease in height of the induced bone, there was an increase in area density of the bone over time. Conclusions: This study demonstrated that rhBMP-2 in a bioerodible particle carrier induced new host bone formation across critical-size mandibular defects. The newly formed bone successfully integrated with existing host bone creating a stable union capable of withstanding the forces of masticatory function in a canine. There was some evidence of early bone resorption (thinning of the cortical bone and decrease in height) in the rhBMP-2-induced bone. The rhBMP-2-induced bone stabilized by 11 months after reconstruction and no further resorption was noted. The percentage of area of the defect replaced by rhBMP-2-induced bone (area density) increased over 30 months. Both roentgenographic photodensitometry and histomorphometry supported the ability of rhBMP-2 to induce structurally stable bone without evidence of bone failure or persistent bone resorption.

OBJECTIVE Determine the prevalence of vestibular and balance disorders in children, rate of complaints of imbalance, and odds ratio of related diagnoses. PATIENTS AND METHODS Retrospective review of pediatric health system during a 4-year period for International Classification of Diseases, 9th Revision, codes related to balance disorders. Identified records were searched for chief complaints related to balance and for codes of related otologic and neuro-otologic diagnoses. RESULTS A total of 561,151 distinct patient encounters were found. Unspecified dizziness was diagnosed in 2,283 patients (0.4%). Also, 22% presented with balance complaints. Peripheral disorders were diagnosed in 159, and central disturbances were diagnosed in 109 (prevalence < 0.0002%). Cumulative prevalence of diagnoses related to balance was 0.45% (2,546/561,151). Of all patients, 5,793 (1.03%) had chief complaint related to balance, and 2,076 (35.84%) were also diagnosed with vestibular disorder. Moreover, 38% with peripheral disturbances and 21% with central disturbances had balance complaints. Odds ratio of syncope was 21× higher than the general pediatric population in patients with unspecified dizziness, and sensorineural hearing loss was 43 times higher in those with peripheral vestibular disorders. In patients with central disorders headache was 16× higher (p < 0.05). CONCLUSION The prevalence of balance disorders in children is low. Children diagnosed with these disorders typically do not present with chief complaint related to balance. Significant associations exist between sensorineural hearing loss, syncope, and headache in children diagnosed with balance disorders.

ObjectiveThe efficacy of the Otologics Fully Implantable Hearing Device (MET) was assessed in adult patients with bilateral moderate to severe sensorineural hearing loss.MethodsSurgical 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.ResultsSix- 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...

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.

Vestibular disorders are becoming an increasingly more common medical problem. As society ages and modern entertainment and recreational activities progress the impact of dizziness on the population is become even more significant. Dizziness not only interferes with the performance of daily activities, but it also represents a serious health problem. Over the last several years, many new diagnostic and treatment modalities have been developed to help manage the dizzy patient. Otolaryngologists occupy a prime position in the treatment algorithm. Otolaryngologists are capable of diagnosing disorders of balance, prescribing medical therapy, performing surgical procedures, or directing the patient to the appropriate rehabilitation regimen. As with any field the development of new diagnostic and treatment procedures has been accompanied by controversies. Over the past several years, the equilibrium committee of the academy has been charged with examining these controversies. This symposium will present some of the controversies in the management of the dizzy patient. After the presenters discuss each issue, there will be an opportunity for audience participation. The controversies to be discussed include: the use of vestibular test apparatus in diagnosing the dizzy patient; the role of vestibular rehabilitation therapy in managing the dizzy patient; the role of medicines in treating patients with a variety of vestibular disorders Meniere’s disease; and what to do next when conservative medical therapy fails.

Eosinophilic granuloma is an uncommon condition that is characterized by unifocal or multifocal osteolytic lesions that often affect the skull. Unilateral lesions of the temporal bone are not uncommon, but bilateral temporal bone lesions are rare. In fact, to the best of our knowledge, fewer than 20 such cases have been reported during the past 40 years. We report a new case of bilateral temporal bone eosinophilic granuloma, and we review the disease process and its treatment.