Middle Ear electromagnetic semi-implantable hearing device: Results of the Phase II SOUNDTEC Direct System Clinical Trial

To assess the safety and efficacy of the SOUNDTEC Direct System, a partially implantable electromagnetic middle ear hearing device. Food and Drug Administration Phase II clinical trial of 103 patients at 10 sites across the United States. Tertiary referral medical centers. Individuals with bilateral moderate to moderately severe sensorineural hearing impairment who had worn optimally fit hearing aids for at least 45 days. Therapeutic intervention included implantation of a 27-mg neodymium iron boron magnet encased in a laser-welded titanium canister onto the incudostapedial joint, followed, after a 10-week healing period, by fitting with a deep earmold coil assembly and activation of the sound processor. Functional gain, speech recognition in quiet and noise, articulation index scores, perceived aided benefit, sound quality judgments, satisfaction, and presence of feedback and occlusion with the Direct System were compared with those of the patients' optimally fit hearing aid. The results of this multicenter clinical trial were submitted to the Food and Drug Administration on April 13, 2001, and are presented here. The results with the use of the SOUNDTEC Direct System compared with an optimally fit hearing aid provided an average 7.9-dB increase in functional gain in the speech frequencies (500-4,000 Hz) and a 9.6 dB gain in high frequencies (2,000, 3,000, and 4,000 Hz). There was a statistically significant average increase of 5.3% in speech discrimination. The mean speech perception in noise test score was improved, but the improvement was not statistically significant. Subjective tests using abbreviated profile of hearing aid benefit and the Hough Ear Institute Profile demonstrated scores statistically improved over the hearing aid condition. These subjective tests measured areas such as the presence of occlusion and feedback, speech quality judgments, device preference, and perceived aided benefit. The results of this Phase II clinical trial demonstrate that the SOUNDTEC Direct System provided statistically significant reduction in feedback and occlusive effect as well as a statistically significant improvement in all the following categories: functional gain, articulation index scores, speech discrimination in quiet, perceived aided benefit, patient satisfaction and device preference over the patient's optimally fit hearing aid.