Long-Term Results of Incus Vibroplasty in Patients with Moderate-to-Severe Sensorineural Hearing Loss

Maier, Hannes; Hinze, Anna-Lena; Gerdes, Timo; Busch, Susan H.; Salcher, Rolf; Schwab, Burkard; Lenarz, Thomas

doi:10.1159/000368387

Cited by 23 publications

(15 citation statements)

References 14 publications

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“…Individual results of each coupler group were as follows: RW = 43 dB, OW = 35 dB, Bell = 37 dB, CliP = 27 dB. These values exceed clinically significant improvement, measured at 15 dB HL [Maier et al, 2015]. The average preoperative unaided and postoperative aided free-field thresholds, respectively, at the frequencies 0.5, 1, 2 and 4 kHz for each coupler group in dB HL were as follows: RW = 75.44 and 32.06, OW = 76.79 and 41.60, CliP = 60.00 and 32.90, Bell = 73.40 and 36.60.…”

Section: Audiometric Resultsmentioning

confidence: 71%

Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results

et al. 2016

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Objective: 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. Methods: 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. Results: 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. Conclusion: 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.

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Section: Audiometric Resultsmentioning

confidence: 71%

Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results

et al. 2016

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“…Similar rates were found for other studies using vibroplasty couplers for FMT positioning (4.4-22%) [Busch et al, 2016;Ihler et al, 2014;Zhao et al, 2016]). In addition, VSB implantation with conventional incus or round window vibroplasty concluded revision rates between 3.8 and 18.8% [Gregoire et al, 2018;Maier et al, 2015;Marino et al, 2015].…”

Section: Discussionmentioning

confidence: 99%

Long-Term Outcomes of Vibroplasty Coupler Implantations to Treat Mixed/Conductive Hearing Loss

et al. 2018

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Objective: To evaluate the long-term safety and performance of four different vibroplasty couplers (round window, oval window, CliP and Bell coupler) in combination with an active middle ear implant. Methods: This was a multicentre, prospective, long-term study including 5 German hospitals. Thirty adult subjects suffering from conductive or mixed hearing loss were initially enrolled for the study, 24 of these were included in the final analysis with up to 36 months of postsurgical follow-up data. Bone conduction and air conduction were measured pre- and postoperatively to evalu ate safety. Postoperative aided sound field thresholds and Freiburger monosyllable word recognition scores were compared to unaided pre-implantation results to confirm performance. Additional speech tests compared postoperative unaided with aided results. To determine patient satisfaction, an established quality-of-life questionnaire developed for conventional hearing aid usage was administered to all subjects. Results: Mean postoperative bone conduction thresholds remained stable throughout the whole study period. Mean functional gain for all couplers investigated was 38.5 ± 11.4 dB HL (12 months) and 38.8 ± 12.5 dB HL (36 months). Mean word recognition scores at 65 dB SPL increased from 2.9% in the unaided by 64.2% to 67.1% in the aided situation. The mean postoperative speech reception in quiet (or 50% understanding of words in sentences) shows a speech intelligibility improvement at 36 months of 17.8 ± 12.4 dB SPL over the unaided condition. The signal-to-noise ratio (SNR) improved by 5.9 ± 7.2 dB SNR over the unaided condition. High subjective device satisfaction was reflected by the International Inventory for Hearing Aids scored very positively. Conclusion: A significant improvement was seen with all couplers, and audiological performance did not significantly differ between 12 and 36 months after surgery.

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“…[1][2][3][4][5][6] To date, a few studies focused on long-term audiological or surgical outcomes. Maier et al 7 reported on audiological outcomes in 104 patients and 122 devices implanted in a single center. A study group led by Sterkers et al 8 reported on 125 patients implanted with the VSB, analyzing patient satisfaction using self-assessment scales postoperatively.…”

Section: Introductionmentioning

confidence: 99%

Long‐Term Outcome of Hearing Rehabilitation With An Active Middle Ear Implant

et al. 2018

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Objective To assess the audiological and long‐term medical and technical follow‐up outcomes of an active middle ear implant. Methods This was a retrospective medical chart analysis of all patients provided with an active middle ear implant in a tertiary academic medical referral center between September 1, 1998, and July 31, 2015. Main outcome measures were medical and technical complications, revisions, reimplantations, explantations, coupling approaches, mean time of use, pre‐ and postoperative hearing thresholds, functional hearing gain across frequencies (250–4,000 Hz), and Freiburg monosyllablic word test at 65 dB. Results One hundred and three patients were identified. Fifteen were implanted bilaterally (n = 118 Vibrant Soundbridge devices [MED‐EL, Innsbruck, Austria]). Seventy‐seven devices were implanted for sensorineural and 41 for mixed and conductive hearing loss. Patients used the implant for 6.7 years (range 0.7 months–17.9 years) on average. Ninety‐one patients (77.12%) were using the device at the end of the observation period. An overall complication rate of 16.1% was observed. The revision and explantation rates were higher for devices implanted between 2004 and 2006. The device failure rate was 3.4%. Audiological evaluation showed significant hearing gains for both hearing loss patient groups. Conclusion This long‐term follow‐up reveals the reliability of the active middle ear implant in a single center. Overall complication rate and device failure rate are acceptable. The complication rate was higher during implementation of alternative coupling approaches. The audiological benefit was satisfactory in patients with all hearing loss types. The majority of implanted patients used the implant at the end of the observation period. Level of Evidence 4 Laryngoscope , 129:477–481, 2019

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Long-Term Results of Incus Vibroplasty in Patients with Moderate-to-Severe Sensorineural Hearing Loss

Cited by 23 publications

References 14 publications

Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results

Multicenter Clinical Trial of Vibroplasty Couplers to Treat Mixed/Conductive Hearing Loss: First Results

Long-Term Outcomes of Vibroplasty Coupler Implantations to Treat Mixed/Conductive Hearing Loss

Long‐Term Outcome of Hearing Rehabilitation With An Active Middle Ear Implant

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