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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.

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.

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...

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.