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

Abstract

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.

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

“…The present multicentre study aims to report, confirm and extend evidence of the long-term performance and safety of the VSB system in combination with vibroplasty couplers up to 36 months after VSB surgery. In addition, interim data of the same study collected up to 1 year after VSB [Zahnert et al, 2016] implantation should be substantiated by additional data provided in the present publication.…”

“…Subjects suffered from moderately severe (n = 9) over severe (n = 12) to profound (n = 3) hearing loss. Additional study inclusion and exclusion criteria are reported elsewhere [Zahnert et al, 2016]. The FMT was connected to the stapes (CliP coupler n = 3 or Bell coupler n = 5), the oval window (OW coupler n = 7) or the round window (RW coupler n = 9).…”

“…These vibroplasty couplers are summarized as vibroplasty couplers of the 2nd generation. A detailed description of the surgical method including illustrations of 2nd-generation coupler placement can be found in the preceding publication [Zahnert et al, 2016]. Recently 3rd-generation couplers which can be either placed on the short or the long process of the incus as well as the round window were developed to complement the range of vibroplasty couplers.…”

A Case of Middle Ear Implantation Using the Vibrant Soundbridge in a Patient with Bilateral Mixed Hearing Loss

“…One of the main advantages of VSB in treating mixed or conductive hearing loss is that it can provide vibratory stimulation bypassing the external auditory canal and the damaged ossicular chain, often allowing the overclosure of airbone gap especially at 1-4 kHz. [10][11][12] Another advantage would be being able to be free of an ear level external device which can be a hindrance in radical cavities or auditory canals with chronic infections. 11) In patients with mixed or conductive hearing loss, the FMT of VSB may be connected to the round window, oval window, remnants of the ossicular chain depending on the condition of the middle ear either directly or using various couplers to improve the feasibility of surgical procedures and also the functional outcome.…”

Guideline “Implantable hearing aids”—short version

“…Systems that are in direct contact with the perilymphatic fluid via penetration of the membrane are also included in the definition [10]. Fixation can be achieved via coupling elements [13,14,33], additional prosthesis, and autologous or allogeneic materials [28].…”