Objective: Implantable hearing aids present a new treatment modality for patients suffering from sensorineural hearing loss. The functional gain obtained with the partially implantable Symphonix soundbridge system was evaluated in a clinical study. The audiological results achieved with n = 34 patients over a period of up to three years are presented in this second part of the publication.
Patients and methods: 34 patients have received the Symphonix Vibrant soundbridge system since February 1997. The average age at implantation was 47.2 years (minimum: 18.9 years; maximum: 80.3 years). All patients have had several years of experience with hearing aids, which, however, provided insufficient functional gain or could not be fitted with a conventional hearing aid for medical reasons (such as auditory ear canal problems). All patients fulfilled the audiological selection criteria as they had bilateral moderate to severe sensorineural hearing loss. As a rule, the ear with poorer performance was implanted. All patients were fitted with the audio processor eight weeks after the implantation. The pure tone thresholds, the functional gain, the monosyllable and sentence understanding (Göttinger Sentence Test in quiet and noise) were preoperatively and postoperatively assessed. Standardized self-assessment questionnaires were used to evaluate the subjective benefit (PHAB) and the quality of hearing (HDSS) as compared to the preoperative situation. Further hearing tests were performed after four weeks, three, six, nine, twelve, eighteen, twenty-four and thirty-six months postoperatively. During the observation period of up to three years the audioprocessor was updated several times, most recently with the fully digital three-channel-system Vibrant D. The results obtained were documented.
Results: Postoperatively, the pure tone threshold with the soundbridge system switched off did not change significantly in the implanted ear. All patients had a functional gain that was either comparable to the gain achieved with hearing aids or better. In particular speech-related frequencies showed improved amplification. The free field speech recognition tests revealed higher scores in quiet and in noise. The patients commended the natural sound quality, the lack of feedback, the absence of occlusion and distortion, the improved speech understanding in noise and the favourable cosmetic appeal. Only two patients failed to achieve better results as compared to their performance with conventional hearing aids. No complications, such as a deterioration of hearing due to inner ear damage or a conductive hearing loss, were observed in the long-term.
Conclusions: The Symphonix Vibrant Soundbridge is a new and promising treatment modality for patients suffering from moderate to severe sensorineural hearing loss. Further improvement of the good results can be expected with improved coupling of the transducer to the ossicular chain and further development of signal processing.