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Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results.
- Source :
- Audiology & Neurotology; Oct2016, Vol. 21 Issue 4, p212-222, 11p, 1 Diagram, 1 Chart, 7 Graphs
- Publication Year :
- 2016
-
Abstract
- <bold>Objective: </bold>To evaluate the safety and effectiveness of round window (RW), oval window (OW), CliP and Bell couplers for use with an active middle ear implant.<bold>Methods: </bold>This is a multicenter, long-term, prospective trial with consecutive enrollment, involving 6 university hospitals in Germany. Bone conduction, air conduction, implant-aided warble-tone thresholds and Freiburger monosyllable word recognition scores were compared with unaided preimplantation results in 28 moderate-to-profound hearing-impaired patients after 12 months of follow-up. All patients had previously undergone failed reconstruction surgeries (up to 5 or more). In a subset of patients, additional speech tests at 12 months postoperatively were used to compare the aided with the unaided condition after implantation with the processor switched off. An established quality-of-life questionnaire for hearing aids was used to determine patient satisfaction.<bold>Results: </bold>Postoperative bone conduction remained stable. Mean functional gain for all couplers was 37 dB HL (RW = 42 dB, OW = 35 dB, Bell = 38 dB, CliP = 27 dB). The mean postoperative Freiburger monosyllable score was 71% at 65 dB SPL. The postimplantation mean SRT50 (speech reception in quiet for 50% understanding of words in sentences) improved on average by 23 dB over unaided testing and signal-to-noise ratios also improved in all patients. The International Outcome Inventory for Hearing Aids (IOI-HA)quality-of-life questionnaire was scored very positively by all patients.<bold>Conclusion: </bold>A significant improvement was seen with all couplers, and patients were satisfied with the device at 12 months postoperatively. These results demonstrate that an active implant is an advantage in achieving good hearing benefit in patients with prior failed reconstruction surgery. [ABSTRACT FROM AUTHOR]
- Subjects :
- TREATMENT of deafness
CONDUCTIVE hearing loss
COCHLEAR implants
CLINICAL trials
BONE conduction audiometry
AUDITORY perception testing
BONE conduction
COCHLEA
COMPARATIVE studies
HEARING
HEARING aids
LONGITUDINAL method
RESEARCH methodology
MEDICAL cooperation
MIDDLE ear
PATIENT satisfaction
QUALITY of life
QUESTIONNAIRES
RESEARCH
SPEECH perception
EVALUATION research
TREATMENT effectiveness
Subjects
Details
- Language :
- English
- ISSN :
- 14203030
- Volume :
- 21
- Issue :
- 4
- Database :
- Complementary Index
- Journal :
- Audiology & Neurotology
- Publication Type :
- Academic Journal
- Accession number :
- 119125425
- Full Text :
- https://doi.org/10.1159/000444616