Multiple electrostimulation treatments to the promontory for tinnitus.

OBJECTIVES: To assess the safety and efficacy of multiple sessions of electrostimulation by a transtympanic needle electrode on the promontory for tinnitus relief. STUDY DESIGN: Prospective open, unblinded, uncontrolled clinical trial. SETTING: Tertiary academic referral center. PATIENTS: Ten patients (8 male and 2 female subjects), mean age 50.1 ± 12 years (range, 34-67) with severe unilateral tinnitus completed all stages of the study. Patients with tinnitus duration between 6 months to 3 years were included. INTERVENTION: The patients underwent 3 consecutive 30-minute sessions, every other day, of biphasic, charge balanced electrostimulation pulses to the promontory delivered by a transtympanic needle electrode. MAIN OUTCOME MEASURES: 1) Tinnitus loudness reported by visual analog scale (VAS) between 1 and 10, at baseline, before and after each treatment, and 1, 2, 3, and 4 weeks after the last treatment. 2) Tinnitus Handicap Inventory (THI) questionnaire at baseline and 4 weeks after treatment. 3) Basic audiometry and tinnitus specific tests such as minimum masking level, tinnitus loudness, and pitch. RESULTS: No long-term adverse safety outcomes were noted in physical examination or audiologic evaluation. VAS levels decreased by ≥2 levels in 5 patients (50%) and returned to baseline 4 weeks after treatment. The VAS decrease was found significant (p = 0.048) in those patients. A statistically significant decrease in THI score was noted 4 weeks after treatment. Tinnitus specific tests at that time were unchanged from baseline. CONCLUSION: Multiple sessions of electrostimulation to the promontory seem to be safe and may be beneficial for some tinnitus patients. Further clinical trials are warranted.

An Er:YAG laser endoscopic fiber delivery system for lithotripsy of salivary stones.

BACKGROUND AND OBJECTIVES: Endoscopic applications of Erbium:YAG lasers are still very limited due to lack of appropriate fiber delivery capabilities. Recent reports on potential advantages of this laser for lithotripsy of ureteral stones prompted us to develop an Er:YAG fiber delivery system for endoscopic lithotripsy of salivary stones. We report on the development of this system and its clinical use on 17 patients. STUDY DESIGN/MATERIALS AND METHODS: Ho:YAG and Er:YAG laser fragmentation performances were initially compared. Optimal laser parameters for lithotripsy of salivary stones were then established ex vivo using a commercial dental Er:YAG laser (Lumenis Opusdent 20). Metal hollow waveguides optimized for Er:YAG laser transmission were end sealed with a polished sapphire rod of 0.63 mm diameter and designed to adapt to the Opusdent laser and to a Storz sialoendoscope. The system was tested ex vivo for durability and clinical compatibility at input energies up to 700 mJ, 10-20 Hz. Following Helsinki approval the system was clinically tested on 17 patients with sialolithiasis. RESULTS: Lithotripsy threshold was around 80 mJ/pulse (26 J/cm2) while efficient fragmentation, with microscopic fragments, was observed at an output energy range of 150-300 mJ/pulse. At 10 Hz, fragmentation rates of about 1.8 mm3/second were achieved enabling lithotripsy of a 6 mm stone in about 2 minutes. Front surface damage to the sapphire rod occurred but did not contribute to significant loss in fragmentation efficiency. Of the 21 stones treated clinically, 5 were fully fragmented, 7 were prepared for extraction by mini forceps, and 9 were released from surrounding soft tissues for subsequent removal. Fifteen of the 18 treated glands returned to normal function without any symptoms. CONCLUSIONS: The Er:YAG endoscopic delivery system described is a clinically viable and cost-effective device for a range of hard and soft tissue wet field applications accessible through rigid or semi-rigid endoscopes. Further improvements in the waveguide may allow access also through fully flexible endoscopes.