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Objectives: First, to determine if prosthesis length plays a role in optimizing successful hearing outcomes in stapedotomy surgery; and second, to determine if patient factors such as height are correlated with prosthesis length., Study Design: Retrospective chart review., Methods: Retrospective chart review of patients undergoing stapedotomy surgeries with adequate follow up. Length of prosthesis, pre-/postoperative audiograms, and follow-up data were obtained., Results: The primary group consisted of 227 cases. The prosthesis length ranged from 3.75 mm to 4.75 mm (median 4.25 mm). The greatest improvement in postoperative air-bone gap (ABG) occurred in the 4.25 mm group, and the least in the 3.75 mm group. Patient height showed a positive, although weak, correlation with prosthesis length. No findings reached statistical significance., Conclusion: Accurate measurement of prosthesis length is important for successful postoperative hearing outcomes. There is a positive but not significant correlation between patient height and prosthesis length., Level of Evidence: 4. Laryngoscope, 128:722-726, 2018., (© 2017 The American Laryngological, Rhinological and Otological Society, Inc.)

Objective: To evaluate the effect of piston diameter in primary stapedotomy for otosclerosis patients measured by hearing outcome., Data Sources: PubMed, Embase, and the Cochrane Library., Review Methods: A systematic search was conducted. Studies reporting original data on the effect of piston diameter on pure-tone audiometric results in patients undergoing primary stapedotomy for otosclerosis were included. Relevance and risk of bias of the selected articles were assessed. Studies with low relevance, high risk of bias, or both were excluded. Absolute risks and risk differences, means and mean differences, and 95% confidence intervals were extracted., Results: Twelve studies with moderate to high relevance and moderate risk of bias were included for data extraction. Air-bone gap closure to 10 dB or less was assessed in six studies, the majority of which did not show a statistically significant or clinically relevant difference between two pistons with a different diameter. More importantly, the differences that were found were not consistently in favor of smaller-diameter pistons or larger-diameter pistons. Mean postoperative air-bone gap ranged from 3 dB in favor of a smaller-diameter piston to 3 dB in favor of a larger-diameter piston across four studies. Permanent sensorineural hearing loss was assessed in eight studies and occurred in only one study. In this study, no difference was found between a 0.4-mm-diameter piston and a 0.6-mm-diameter piston., Conclusion: There is not sufficient evidence to support the superiority of the use of a larger-diameter piston compared to a smaller-diameter piston for primary stapedotomy in otosclerosis patients., (© 2015 The American Laryngological, Rhinological and Otological Society, Inc.)

Background: Surgical intervention within the area of the middle ear always leads to alteration of conditions in its biomechanical system. This fact may provide an explanation for the lack of expected auditory outcome, although an apparently good anatomic outcome was obtained. In the case of stapedotomy, the majority of patients report lack of satisfactory results for frequencies above 2,000 Hz. The effect has not been experimentally investigated yet., Methods: This study, conducted in four human temporal bones, yielded a record of round-window membrane vibration amplitude and phase in the frequency function (400 Hz-10 kHz) at the sound intensity level of 90 dB administered to the external auditory canal in a physiologic condition and following implantation of a Teflon piston stapes prosthesis. The procedure of experimental stapedotomy was performed with the tympanic membrane preserved from the maximally dilated approach through the posterior tympanotomy., Results: Stapes Teflon piston prosthesis implantation was found to cause approximately fivefold lower amplitude of round-window membrane vibrations compared to a physiologic situation for frequencies above 2 kHz in particular., Conclusions: After stapedotomy, with the use of a Teflon piston prosthesis, stimulation of inner ear structures diminishes, especially in higher frequencies., (Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc.)

Objectives/hypothesis: To compare short-term hearing results in patients undergoing laser stapedotomy for primary otosclerosis using either the flexible potassium titanyl phosphate (KTP) or CO(2) laser fiber., Study Design: Prospective nonrandomized clinical study at a tertiary referral center., Methods: Two hundred fourteen patients undergoing 214 stapedotomies for otosclerotic stapes fixation were enrolled in this study from January 2008 to January 2010. Comparative analyses were made between a group of 107 patients who underwent stapedotomy with the flexible KTP laser fiber and 107 patients who underwent stapedotomy with the flexible CO(2) laser fiber. Preoperative and postoperative audiometric evaluation at 3 months using conventional audiometry, namely, air-bone gap (ABG), bone-conduction thresholds, and air-conduction thresholds, were assessed., Results: In the KTP laser group the postoperative ABG was 4.3 dB compared to 3 dB in the CO(2) group, which is a mean difference of 1.3 dB (95% confidence interval [CI], -0.3 to 2.8; P = .10). Of the patients from the KTP group, 92% had a postoperative ABG of 10 dB or less, as compared to 97% in the CO(2) group (mean difference 5%; 95% CI, -10 to 1; P = .14). The postoperative ABG at 4 kHz was 4.9 dB in the KTP and 2.2 dB in the CO(2) group, which is a mean difference of 2.7 dB (95% CI, 0.6-4.7, P = .01). No sensorineural hearing loss was reported., Conclusions: The use of the CO(2) laser fiber appears to be associated with slightly better hearing results than the KTP laser fiber, especially when assessed at the 4 kHz frequency.

Objective: To present our mid-term results of our multicenter study using the Nitinol self-crimping stapes piston, focusing on the interindividual variations of postoperative air-bone gap closures (ABGC), postoperative hearing results, and postoperative recurrences of conductive hearing loss and to compare these findings with our pilot group of patients., Study Design: Prospective, multicenter cohort study involving three academic tertiary care referral centers from Australia, Switzerland, and the United States., Methods: Ninety patients with otosclerosis undergoing laser-stapedotomy with the Nitinol stapes piston were matched to reference patients from our titanium piston database. The effects of the self-crimping Nitinol piston on the postoperative ABGC, the postoperative interindividual air-bone gap (ABG) variations, and the postoperative hearing results were investigated 3, 6, 12, 18, and 24 months postoperatively. These data were statistically compared with the results of the control patients in our titanium stapes piston database and the results of our previously published pilot study., Results: The mean postoperative ABG and the interindividual variations of the postoperative ABG continue to be significantly smaller in the Nitinol group; the extent of ABGC now is significantly larger in the Nitinol piston group. The postoperative mid-term stability of ABGC was similar in both groups. No adverse reactions occurred during follow-up., Conclusion: Our mid-term results continue to show that the self-crimping shape memory alloy Nitinol stapes piston overcomes the limitations of manual malcrimping in stapedotomy, thus simplifying and optimizing the surgical procedure. This so far has allowed reliable, safe, and consistent ABGC in patients with otosclerosis.

Objective: To describe a newly designed microforceps for easy and stable crimping of a prosthesis loop to the incus' long process in stapes surgery, Results: We developed a crimping tool with two innovative improvements. First, the tip of the crimping device is arcuated and thus able to span the loop of the prosthesis entirely around the incus long process. Second, a retaining spring is implemented into the handle. This passive opening mechanism of the crimper avoids the switch from flexor to extensor muscle group movements in the forearm of the surgeon while switching from crimping to unclosing the forceps. This maneuver, which is considered the most delicate in ear surgery, can be performed by variations of the flexor muscle group tonus only., Conclusion: The new crimping tool has proved to be reliable in firm attachment of the prosthesis' loop to the incus long process. Furthermore, because of the passive open-up mechanism movements of the surgeon's hand, wriggling excursions of the tip of the forceps are minimized and the risk of incus luxation is reduced.

Objective: Manual piston malcrimping in stapedotomy may be the major cause of the occurrence of the significant, interindividual variations of postoperative air-bone gap (ABG), air-bone gap closures (ABGC), and postoperative recurrences of conductive hearing loss. To eliminate the effects of manual crimping on stapedotomy outcomes, the self-crimping, shape memory alloy Nitinol stapes piston was investigated and hearing evaluated., Study Design: Prospective, preliminary case-control study in a tertiary care referral center., Methods: Sixteen patients with otosclerosis undergoing reversed stapedotomy using the Nitinol stapes piston were matched to reference patients out of our conventional titanium piston database. The effects of the self-crimping Nitinol piston on the postoperative ABGC, the postoperative air-bone gap (ABG) variations, and the postoperative short-term hearing results were investigated 3, 6 and 9 months postoperatively. These data were statistically compared with the results of the control patients in our titanium stapes piston database., Results: The mean postoperative ABG and the interindividual variations of the postoperative ABG were significantly smaller in the Nitinol group, the extent of ABGC greater in the Nitinol piston group, but not significant. The postoperative short-term stability of ABGC was similar in both groups. No infections or adverse reactions occurred during follow-up., Conclusion: Our preliminary results suggest that the self-crimping shape memory alloy Nitinol stapes piston eliminates the limitations of manual malcrimping in stapedotomy, thus optimising the surgical procedure. This allows reliable, safe, and consistent air-bone-gap closure in patients with otosclerosis up to 1 year after surgery.

Objective: To compare the effectiveness of two stapes prostheses in hearing improvement of patients undergoing stapes surgery for otosclerosis., Study Design: Retrospective chart review., Methods: Titanium and Teflon wire stapes prostheses were compared with regard to effectiveness in closing the air-bone gap. The charts of 461 stapedectomies performed by one surgeon from 1996 to 2001 were reviewed. Patients who underwent stapedectomy for reasons other than otosclerosis, revision cases, and those with inadequate preoperative or postoperative bone-conduction threshold data were excluded. Small fenestra technique using either laser or drill was used for all patients. Inclusion criteria were met by 218 patients. Patients were then grouped according to type of prosthesis used, and hearing outcomes were compared. Measured outcomes were four frequency air-bone gap closure, pure-tone threshold, and rate of sensorineural hearing loss (SNHL)., Results: The study group was comprised of 35 titanium and 183 Teflon wire prostheses. Closure of the air-bone gap to less than 10 dB was achieved in 86% of the patients with Teflon prosthesis compared with 71% of those with titanium prostheses. The groups were equivalent in regard to site of otosclerotic disease as well as technique, laser or drill, used to create the fenestra. Rate of SNHL was low for both groups and not significantly different., Conclusions: Both prostheses provided comparable results, although the Teflon platinum wire prosthesis was slightly superior. The smaller numbers in the titanium group may confound these results. The design of the titanium prosthesis provides a crimp that is circumferential around the incus, and that prosthesis was selected in cases with a narrow incus. The selection bias may also influence the results seen in this study.

Objective: To assess the safety and efficacy of a new semi-implantable electromagnetic hearing device, the SOUNDTEC Direct Drive Hearing System (DDHS), and to compare its performance with that of subjects' previously worn, optimally fit hearing aids. Preliminary results for the first 10 subjects are presented., Study Design: The protocol specified in the Investigational Device Exemption is used in this ongoing FDA phase II 100-subject multicenter clinical trial., Methods: For baseline, each subject is tested wearing his or her own optimally fit hearing aid in the ear to be implanted. Six-month postoperative outcome measures using the SOUNDTEC DDHS are compared with the baseline. Multiple objective and subjective outcomes (as listed under Results) were measured., Results: When compared with the subjects' optimally fit hearing aids, the SOUNDTEC DDHS provided an average improvement of 52% in functional gain (250-6000 Hz), 22% in aided thresholds, 3.8% for speech discrimination in quiet, 17% for speech in noise, 13.1% in articulation index scores, 28% in aided benefit, 27.3% in sound quality of speech, and a 16.7% increase in overall subject satisfaction. In addition, with the SOUNDTEC DDHS, subjects reported absence of acoustic feedback, little or no occlusive effects, and more natural sound perception., Conclusion: Analysis of data on the first 10 subjects using the SOUNDTEC DDHS indicates positive outcomes regarding safety and efficacy, although the small sample size is not sufficient to permit valid statistical inferences to be drawn from our preliminary data. Results also demonstrate improvement in performance compared with the subjects' optimally fit hearing aids and an improvement in quality of life as demonstrated by objective and subjective tests and measures.

Objective: To improve the techniques required to perform a stapedotomy without prosthesis (stapedioplasty)., Study Design: New infrared lasers were evaluated for potential use in otological surgery in guinea pigs. A prospective human trial of 34 primary stapes operations using the Argon ion laser was performed, with 11 stapedioplasties and 23 conventional stapedotomies as controls., Methods: Laser-tissue interactions were evaluated for temporal bone and live guinea pig tissues, measuring crater histology and labyrinthine temperature elevations. Patients undergoing stapedioplasty had Argon ion laser cuts with endoscopic assistance made in the anterior crus and footplate to mobilize the posterior segment of the stapes while the anterior portion remained fixed., Results: Diode laser (808-nm) vaporization craters and temperature elevations in the vestibule were suitable for clinical use. Overall, stapedioplasty patients' hearing was improved with air-bone gap closure to a mean of 8.3 dB (SD +/- 9.8 dB)., Conclusions: Patients with anterior footplate otosclerosis are candidates for stapedioplasty preserving the annular ring and stapes tendon and eliminating prosthesis complications. High-resolution small endoscopes, coupled with Argon ion or diode lasers promise to improve stapes visualization, enhancing the ability to perform minimally invasive surgery on the stapes footplate.

Seventy-four revision stapedectomies performed consecutively over 10 years (1986 to 1995) were reviewed retrospectively. The most common intraoperative findings were incus erosion, prosthesis displacement, and oval window closure. Incus erosion was more frequently associated with multiple revisions. The postoperative results were reported using the conventional method (postoperative air minus preoperative bone) as well as the guidelines recently published by the American Academy of Otolaryngology--Head and Neck Surgery (postoperative air minus postoperative bone), with success rates of postoperative air-bone gap closure to within 10 dB after revision surgery of 51.6% and 45.6%, respectively. Patients with persistent conductive hearing loss (large residual air-bone gaps) after primary stapedectomy had poorer postrevision hearing results. Sensorineural hearing loss (defined as a drop in bone pure-tone average of more than 10 dB) occurred in four cases (5.4%). The number of revision surgeries, variations in operative techniques using laser or drill, and the ossicle to which the prosthesis was attached did not statistically affect the postoperative air-bone gaps. These results were compared with previously published data.

Cadaveric human temporal bones, cadaveric rabbits, and live rats were used to demonstrate the utility and safety of the erbium:yttrium-scandium-gallium-garnet (Er:YSGG) laser for otologic applications. The shallow penetration in water of this wave-length and its ability to ablate bony tissue with minimal collateral thermal effects spare underlying and adjacent structures and make it appealing for stapedotomy. The authors were able to satisfactorily perform small fenestra stapedotomy, atticotomy facial nerve decompression, and mastoidectomy. Temperature measurements from the round window area during Er:YSGG stapedotomy recorded an elevation of less than 2 degrees C, which is well within acceptable limits. An acoustic shock produced at the impact site is the major disadvantage and requires further in vivo investigation of the transient and sustained deleterious effects away from the application site. This work supports further investigation into potential applications of the Er:YSGG laser in otology.

Obliterative otosclerosis has been a challenge since the advent of stapes surgery. "Drill-out" procedures have had a generally poorer prognosis than conventional stapes surgery because of excessive bleeding, acoustic trauma from the burr, and reclosure of the oval window by otosclerosis. In this report, we describe our early experience using a hand-held fiberoptic argon laser for small fenestra stapedotomy in 10 cases of obliterative otosclerosis. Closure of the air-bone gap to within 10 dB was seen in 100% of the patients. There was no significant sensorineural hearing loss, vertigo, or facial weakness. Argon-laser stapedotomy using a hand-held fiberoptic system is a safe and effective alternative to drill-out stapedotomy in cases of obliterative otosclerosis.

This study was based on a detailed review of 503 cases of otosclerosis that were operated upon by me from 1961 to 1968. The vicissitudes of anesthesia, disequilibrium, dead ears and unexpected emotional abberations as well as legal and technical problems are discussed. Stapedectomy has been one of the most rewarding and technically challenging procedures that has come along in my career so far in medicine.

The use of the argon laser in chronic ear disease and otosclerosis surgery is reviewed. Its advantages and limitations are discussed, and safe parameters for use established. The argon laser is an effective tool to remove, cut, and coagulate tissue. It was used in over 500 microsurgical otologic procedures without deleterious effects. One hundred primary laser stapedotomies were performed, and the audiological results were compared to those obtained using conventional small fenestra stapedectomy techniques. No significant statistical difference was present in the audiologic results after 1 year of observation. The clinical course of the laser stapedotomy patients suggested this technique was less traumatic than conventional techniques.

A total of 2,985 stapedectomies were done during the 25-year period 1959 to 1984 in a busy urban otologic practice. One hundred twenty-three of these cases were found to have obliterative otosclerosis which resulted in a drill-out stapedectomy. Postoperatively, a minimum of 2 years follow-up yielded 98 of the original 123 drill-out cases constituting the study group. Several parameters will be evaluated: 1. Initial hearing gain (measured 3 months after surgery), 2. long-term hearing results (measured 2 years and beyond), 3. additional sensorineural hearing loss, and 4. probability of bilateral obliterative disease.