There is currently no standardized method for reporting audiological, surgical and subjective outcome measures in clinical trials with active middle ear implants (AMEIs). It is often difficult to compare studies due to data incompatibility and to perform meta-analyses across different centres is almost impossible. A committee of ENT and audiological experts from Germany, Austria and Switzerland decided to address this issue by developing new minimal standards for reporting the outcomes of AMEI clinical trials. The consensus presented here aims to provide a recommendation to enable better inter-study comparability.

Objective: To evaluate the audiological and subjective benefit from hearing rehabilitation with an active bone conduction implant in subjects with single-sided sensorineural deafness (SSD). Study Design: Prospective, multicenter, single-subject repeated measures. Setting: Tertiary referral center, five clinics in Germany and Switzerland. Patients: Seventeen subjects aged 18 years and older with severe to profound unilateral sensorineural hearing loss and contralateral normal hearing were followed up for 24 months. Intervention: Active bone conduction implant. Main Outcome Measures: Speech understanding in noise was assessed in three situations: with signal from front, deaf, or normal hearing side (with noise from front in all set-ups). Subjective benefit was evaluated using the Speech, Spatial, and Qualities of Hearing (SSQ-B) and Bern Benefit in Single-Sided Deafness (BBSS) questionnaire.Results: When the signal was coming from the deaf side the mean improvement of the speech reception threshold in noise ranged from 1.5 up to 2.2 dB with the device and was statistically and clinically significant at all tested timepoints. No significant difference between the aided and unaided situation was found when signal and noise were coming from the front. With the signal from the normal hearing side no clinically significant difference, that is, greater than 1 dB between the aided and unaided situation was found. The SSQ-B and BBSS questionnaire showed an overall improvement with no significant difference between time points. Conclusions: The study demonstrates long-term efficacy and benefit of the device in adults with SSD. Patients reported substantial and persistent subjective benefit from the active bone conduction implant.

The objective of this study was to develop a method of cement microapplication using glass-ionomeric cement. The results of an experimental study to design a microapplication method of glass-ionomeric cement (Ionocem^®) are presented. Typical middle ear implant materials, as well as human temporal bones and middle ear ossicles, were used to test the efficiency of this application method. Two different versions of Ionocem^®, low and normal viscosity, were tested under different temperatures and with several application tools. Sufficient processing time could be achieved by cooling the cement down to 4°C. A subcutaneous insulin syringe with a milled-off tip proved to be cost-effective, efficient and versatile. Using this instrument, durable and secure cementation between the parts tested could be achieved. This method may be of significant importance in otologic research and microsurgical routine. In part 2, experimental animal results will follow, as the method portrayed was used to secure parts of a totally implantable middle ear hearing device.

An experimentally developed technique for microapplication of low-viscosity glass ionomeric cement (see part 1) was tested in animals over a 6-month period. The cement was used to firmly connect gold with titanium and gold with middle ear ossicles in 22 adult foxhounds. After a 6-month period of acoustic stimulation via parts of an implantable hearing aid, the finely applied glass-ionomeric cement was integrated in situ, stable and caused no adverse reactions. The microapplication technique used proved to be easy, effective and provided long-term stability.