Phase III results with a totally implantable piezoelectric middle ear implant: Speech audiometry, spatial hearing and psychosocial adjustment

Author： Zenner Peter Limberger Annette Baumann Joachim Reischl Gabriele Zalaman Ilse Mauz Paul Sweetow Robert Plinkert Peter Zimmermann Rainer Baumann Ingo De Maddalena Harry Leysieffer Hans Maassen Marcus

Publisher： Informa Healthcare

ISSN： 0001-6489

Source： Acta Oto-Laryngologica, Vol.124, Iss.2, 2004-03, pp. : 155-164

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Abstract

Objective To evaluate the treatment efficacy of an electromechanical middle ear amplifier implant (AI) in patients with chronic moderate-to-severe sensorineural hearing loss (SNHL). The AI is a piezoelectric system with a sound processor and a rechargeable battery within a hermetically sealed titanium canister. Its titanium-sealed microphone is placed in the bony region of the ear canal. The incus-coupled transducer (actuator), which is also inside a titanium casing, is fastened to the adjacent bone. Material and Methods This was a phase III study comprising 20 intention-to-treat patients. Telemetrical adjustments followed electromechanical amplifier implantations. We used a word recognition test as our primary efficacy measure (Freiburg Speech Recognition Test; DIN 45621). Secondary efficacy measures were the sentence comprehension test (Goettinger Satztest, 1996) for auditory orientation within noisy and quiet environments and a psychosocial adjustment test (Gothenburg Profile Test, 1998). The 6-month follow-up comprised a complete medical examination. Nineteen patients completed the study (per-protocol patients; 100% reference). Results Seventeen patients (89%) demonstrated improved binaural recognition of phonetically balanced monosyllables. Fourteen postoperative patients (74%) attained a perfect score (100%) on this test, compared to only 3 preoperative patients (16%). Thirteen patients (68%) reached the sentence recognition threshold at a 2:1 dB signal-to-noise ratio during noisy trials. Correct identification of the noise source direction in the horizontal plane occurred in 89% of the trials. The Gothenburg Profile Test scores showed that the subjective evaluation of hearing, orientation, social behavior and self-confidence increased from 48% to 88%. Three patients did not benefit from the implant. Conclusion Treatment of SNHL with a totally implantable hearing system can be an efficient method for those patients unable to wear hearing aids. However, in order to avoid implantation in non-responders, there is a need for more specific audiological indication criteria.