The acceptance and voice quality of a new voice prosthesis 'Vega High performance' - a feasibility study.

BACKGROUND

The Provox Vega High Performance (PVHP) is a newly developed voice prosthesis (VP) with an aim to achieve a longer and more predictable lifetime.

OBJECTIVES

This feasibility study aims to assess patient acceptance of the PVHP VP, evaluate adverse events, voice quality, and device lifetime.

METHODS

Laryngectomized patients previously using a Provox Vega or ActiValve Light were included. Acceptance and voice outcomes were evaluated at two-time points with a 2-week interval. Baseline measurements were taken with the standard VP, followed by placement of the PVHP for the 2-week assessment.

RESULTS

Fifteen participants completed the study, with thirteen being initial Vega-users. PVHP acceptance was 87% 2 weeks after placement. Median device lifetime for all VPs was 64 d (range 14-370). In the subgroup without periprosthetic leakage, the median device lifetime was 101 d (range 31-370). Acceptance dropped to 40% after device failure. Voice quality did not differ between PVHP and baseline VP. The most reported adverse event was PVHP valve stickiness (46%).

CONCLUSION AND SIGNIFICANCE: Acceptance of the PVHP is largely dependent on device lifetime, decreasing from 87% to 40% after leakage or replacement. Voice quality remains consistent across different VPs. Developing a long-lasting VP remains a challenge.