Eric M. Kraus

Envoy Esteem Totally Implantable Hearing System: Phase 2 Trial, 1-Year Hearing Results

Objectives. (1) To assess outcomes of the Envoy Esteem Totally Implantable Hearing System as measured by hearing results compared with preimplant baseline unaided (BLU) and best-fit aided conditions (BLA) and (2) to determine safety of the device. Study Design. Prospective, nonrandomized, multicenter, subject-as-own-control, US Food and Drug Administration (FDA) trial. Setting. Private practice and hospital-based. Subjects and Methods. Between January 2008 and August 2009, an FDA trial was performed at 3 sites. Fifty-seven subjects with bilateral, mild to severe sensorineural hearing loss, with discrimination greater than 40%, were implanted. Implanted components were (1) a sound processor and (2) 2 piezoelectric transducers (a sensor and a driver). A sound processor was implanted in the temporal bone. Transducers were coupled to the ossicles. Devices were activated 2 months postimplant. Hearing results were compared with ipsilateral BLU and BLA. Results. Speech reception thresholds (SRTs) improved from BLA of 41.2 dB to 29.4 dB with the Esteem (P ≤ .001). Word recognition score (WRS) at 50 dB hearing level (HL) improved from BLA of 46.3% to 68.9% with the Esteem. Pure tone averages improved by 27 ± 1 dB (confidence interval, 30-25). There were no changes in bone conduction. QuickSIN results showed no change. There were 6 serious adverse device effects: 2 wound infections (1 resolved medically, 1 required explantation), 1 delayed facial paralysis that resolved with medication, and 3 revisions due to limited benefit. Conclusion. Phase 2 results at 12 months post implant demonstrated that (1) hearing results with the device are statistically superior to baseline best-fit hearing aids for SRT and WRS and (2) the device is safe.

Medical Malpractice and Rhinology

Background Physicians facing malpractice litigation are in uncharted territory. The language, concepts, rules, and strategies of the legal system are foreign to science-based physicians. Understanding the statistics of rhinology malpractice litigation may aid the physician to cope with the assault of a claim. Methods Information from the 2006 Physician Insurers Association of America (PIAA) and the 2006 PIAA Risk Management Report (RMR)–Otorhinolaryngology were searched for claims data referable to the nose, nasal chamber, and paranasal sinuses. The PIAA data sharing report (DSR) is the largest single resource of malpractice claims data containing both settlement and trial judgment information. Results The nose, nasal cavity, and paranasal sinuses represent nearly two-thirds of the total indemnity paid for improper performance from otolaryngology head and neck surgery (Oto-HNS) medical malpractice claims between 1985 and 2005 based on claims information. Improper performance accounts for 50.3% of total monies paid (

Profound High-Frequency Sensorineural Hearing Loss Treatment With a Totally Implantable Hearing System

107.6 million of

Hearing results with clothespin ossiculoplasty: preliminary report on the Kraus Modified Schuring Ossicle-Cup Prosthesis (Clothespin Prosthesis).

213.6 million) to resolve Oto-HNS claims in this period. Of nearly 2400 operative claims closed in the period of 1985–2005, 34.1% involved procedures on the nose and sinuses. In the past 6 years,

Totally implantable hearing system: Five-year hearing results

103.5 million indemnity has been added to the otolaryngology total. Conclusion The area of endoscopic sinus surgery has substantially contributed to Oto-HNS claims in the PIAA DSR. Despite malpractice being a cost of medical practice, every claim is perceived as an assault on the surgeons competence. Ensuring informed consent and complete documentation may assist the provider in defending their care.

Esteem Treatment of Profound High-Frequency Hearing Loss

Objective This study seeks to assess the efficacy of the Envoy Esteem totally implantable hearing device in treating profound high-frequency sensorineural hearing loss. Patients Five patients with profound high-frequency hearing loss participating in a prospective, multi-center, nonrandomized Food and Drug Administration clinical trial. Intervention Implantation with Esteem totally implantable hearing device and comparison to baseline unaided and aided conditions. Main Outcome Measure Speech reception threshold and word recognition scores (WRS) at 50 dB HL presentation level. Results Preoperative speech reception threshold improved from an unaided 65 dB and aided 48 dB average to 26 dB with the Esteem at 12 months. WRS at 50 dB scores improved from an unaided 10% and aided 23% average to 78% postoperatively. Conclusion The Esteem totally implantable middle ear hearing device provides appreciable functional gain and improvement in WRS to rehabilitate hearing in patients with a profound high-frequency sensorineural hearing loss.

09:10: Phase II Results: Esteem Totally Implantable Hearing System

The clothespin partial ossicular replacement prosthesis (PORP) is designed to Increase Joint stability during incus replacement ossiculoplasty. Fundamental modifications have been made in the Schuring ossicle-cup, which include a forked well, increased well wall thickness and length, and a flexible tip disk added to the shaft. The forked well functions like a straight clothespin rather than an inverted cup. The forked well enables the clothespin prothesis to slide down over the stapes superstructure, between the facial nerve canal and the promontory, to form a stable, mortise-and-tenon prosthesis-stapedial joint. Joint stability is enhanced because the inferior tine of the forked well is able to lever against the inferior surface of the stapes superstructure, creating a counterforce to gravity. This is in contrast to the more unstable ball-and-socket joint created by most partial ossicular replacement prostheses when they articulate with the stapes capitulum. The addition of a flexible disk to the shaft tip produces a tight, stable union between the prosthesis and the ossicular cap by increasing resistance at the shaft-ossicle interface. Fluoroplastic composition maximizes Intraoperative versatility and reliability while the ossicle cap minimizes extrusions. One-year hearing results for twelve chronic ear patients with mobile stapes undergoing clothespin ossiculoplasty during intact canal wall tympanomastoidectomy revealed postoperative air-bone gaps within 20 dB in 92% of cases. The mean postoperative air-bone gap was 8.9 dB, and the mean Improvement in air-bone gap was 14.4 dB. These results are attributable to greater prosthesis stability provided by the time-tested mortise-and-tenon joint concept rather than a ball-and-socket joint in a reconstructive situation in which stability is critical.

Down syndrome and the otolaryngologist

1) To provide long‐term hearing outcome measures of a totally implantable hearing system (implant) and compare to the baseline unaided (BLU) and baseline aided (BLA) conditions, and 2) discuss relevant safety measures.

Congenital primary embryonal carcinoma of the forehead in a female infant

been diagnosed. Special focus was on the age at diagnosis, the localization, and the size of the tumor. The size of the tumor was registered as either intrameatal or with the largest extrameatal diameter. Incidence: The annual number of diagnosed VS has increased from 15 in 1976 to 120 in 2004. Since 2004 the annual number of diagnosed cases has decreased. The size of the diagnosed tumors has decreased from a median of 35 mm in 1979 to 10 mm in 2009. In the first years the large and giant tumors dominated, in contrast to the recent years where the intrameatal and small tumors dominated. The median age at the time of diagnosis has been slowly increasing from 50 years in the beginning of the period to almost 60 years in the end of the period. In patients with 100% speech discrimination, hearing seems to be stable, even after 10 years. In patients with even a slight discrimination loss at diagnosis, almost half lose good hearing during wait and scan. Discussion: If the decreasing size of the tumor and the increasing incidence of VS should be explained only by earlier diagnosis and easier access to MR scanning one should expect that the median age at the time of diagnose would decrease simultaneously. In our study, the median age at the time of diagnosis has been almost unchanged through the 33 year long period. This paradox can be explained by the fact that with the easier access to MR scanning, the examination has been offered also to the elderly patients, in whom the small and intrameatal tumors are dominating. CONCLUSION: The annual number of diagnosed vestibular schwannomas is increasing, the tumor size is decreasing, and the age at diagnosis is increasing. About 25% of tumors are growing and in patients with 100% speech discrimination, good hearing remains even after several years.

Skull preparation using the enzyme-active detergent technique

diagnosing various types of hearing loss. METHODS: Prospective randomized study investigating the validity of the hum test to diagnose hearing loss. One hundred consecutive patients presenting to a subspecialty neurotologic clinic were randomly assigned to the study over a four-month period. Patients were asked to hum and report which side they heard the hum. Tuning fork Weber test at 512Hz as well as a full audiologic profile was done and blindly correlated to the results of the hum test. RESULTS: The hum and Weber test had a 95% correlation to one another and to the pure tone audiogram in identifying conductive hearing loss. The tests had a 70% correlation to one another in diagnosing sensorineural hearing loss. CONCLUSIONS: The hum test is an accurate means of remotely diagnosing conductive hearing loss without the need for patient training or instrumentation. The test can easily be performed remotely by an otolaryngologist or even general physicians with minimal training to confirm conductive hearing loss and prevent unnecessary office visits.